| 16 Apr 2015 | Well at Walgreens Maximum Strength Comfort Gel 12 FL OZ (355 mL) bottle, | Tarmac Products, Inc. | Drug | Class II | 3 |
| 14 Apr 2015 | Flurandrenolide Tape, USP, 4 mcg per sq cm, Rx Only. Distributed By: Actavis Pharma, Inc., Parsippany, NJ 07054, Manufactured By: 3M Company, St. Paul, MN, 55144. Labeled as A) Cordran Tape, Small Rolls, 24 in x 3 in, NDC: 52544-044-24, B) Cordran Tape, Large Rolls, 80 in x 3 in, NDC: 52544-044-80, C) Haelan Tape… Event 70987 | Actavis Laboratories | Drug | Class III | 1 |
| 8 Apr 2015 | La Guadalupana Salsa Verde Vegan Tamales are packed in a bulk plastic bag inside of a corrugated box and are stored frozen or refrigerated until cooked for consumption. Event 70964 | La Guadalupana Wholesale Co Inc | Food | Class I | 1 |
| 7 Apr 2015 | HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use. Event 70948 | Catheter Research, Inc | Device | Class II | 1 |
| 7 Apr 2015 | 0.9% Sodium Chloride Injection, USP, 100 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira Inc., Lake Forest, IL, 60045, NDC: 0409-7101-67 | Hospira Inc. | Drug | Class II | 1 |
| 6 Apr 2015 | Borden Good 2 Gether, UPC: 5300001112, Sharp Cheddar Cheese with Pretzels, Net Wt 2 0z (57 g), Dist. By DFA Dairy Farmers of America, PO Box 909700, Kansas City, MO 64190. | Dairy Farmers OF America Inc | Food | Class II | 4 |
| 31 Mar 2015 | GetGo GNG 7 Inch Italian Sub Sell By: (up to and including) 04/02/15 Net Wt: 6.0 Oz. Contains: Soy, Milk, Wheat UPC: 25567 20399 GetGo from Giant Eagle Distributed by Giant Eagle, Inc., Pittsburgh, PA 15238 Sandwich is wrapped in plastic. | Giant Eagle, Inc. | Food | Class I | 2 |
| 30 Mar 2015 | VasoNova Vascular Positioning System (VPS ) G4 Console Catalog number VPS-G4C Cardiovascular: The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. Event 70927 | VasoNova, Inc. | Device | Class II | 1 |
| 30 Mar 2015 | ProTrack Microcatheter; Product Usage: The ProTrack Microcatheter is a sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires. | Baylis Medical Corp * | Device | Class II | 1 |
| 30 Mar 2015 | OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Manufactured by: OriGen Biomedical. OriGene VV13F Reinforced Dual Lumen Catheter indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life… | OriGen Biomedical, Inc. | Device | Class I | 1 |
| 26 Mar 2015 | Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a wound or burn on the skin, provide a moist wound environment and protect against abrasion, friction, desiccation and contamination. Event 70838 | PhotoMedex, Inc. | Device | Class II | 1 |
| 26 Mar 2015 | Cartia XT (diltiazem HCl extended-release capsules, USP), Once-A-Day Dosage, 300 mg, 90-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA --- NDC 62037-0600-90 | Actavis Laboratories, FL, Inc. | Drug | Class III | 1 |
| 26 Mar 2015 | Silver Lake Easter Egg Cookies, NET WT. 8 OZ (226g), UPC 0 37695 49817 1. Silver Lake Cookie Company, Inc. 141 Freeman Ave., Islip, NY 11751. MADE IN THE USA. Event 70855 | Silver Lake Cookie Co., Inc. | Food | Class I | 1 |
| 25 Mar 2015 | Sentec, V-Sign Sensor 2 (REF VS-A/P/N), Reusable / Nonsterile / Waterproof, SenTec AG, CH-4106, Therwil, Switzerland. The SenTec Digital Monitoring System (SDMS) is used for continuous and non-invasive monitoring of transcutaneous carbon dioxide tension (tcPCO2), oxygen saturation (SpO2), and pulse rate (PR). | SenTec AG | Device | Class II | 1 |
| 25 Mar 2015 | CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01 Event 70851 | CSA Medical | Device | Class II | 1 |
| 25 Mar 2015 | TIGERPAW System II, Part number C-TP-1507 (7 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA). | Laax, Inc. | Device | Class I | 2 |
| 25 Mar 2015 | GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets, USP, 2.5 mg/500 mg, 100 ct Bottles, Rx Only. Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724, NDC: 23155-116-01. | Heritage Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 25 Mar 2015 | PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains: Codeine Phosphate 10 mg, Promethazine Hydrochloride 6.25 mg, Phenylephrine Hydrochloride 5 mg, alcohol 7%, (a) 4 fl oz bottle (NDC 0603-1588-54) and (b) 16 fl oz bottle (NDC 0603-1588-58) Rx only, Manufactured for QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811. | Qualitest Pharmaceuticals | Drug | Class III | 1 |
| 24 Mar 2015 | Fluorescein Sodium Ophthalmic Strips USP, 0.6 mg per strip, labeled as 1) Fluorescein GloStrips, individually wrapped strip (NDC 51801-003-01), barcode (01)00351801003012, packaged in a) 100-count strips per carton (NDC 51801-003-40, UPC 3 51801 00340 1); and b) 300-count strips per carton (NDC 51801-003-50, UPC 3… | Nomax Inc | Drug | Class III | 3 |
| 24 Mar 2015 | GETGO California Chix Cobb Salad Sell By: (up to and including) 3/26/15 Net Wt: 14 oz. Contains: Soy, Egg, Milk GetGo Giant Eagle Distributed by Giant Eagle, Inc., Pittsburgh, PA 15238 | Giant Eagle, Inc. | Food | Class II | 2 |
| 23 Mar 2015 | Bard ConQuest PTA Balloon Dilatation Catheter, 12mm Balloon Size, Product Code: CQ-75124. | Bard Peripheral Vascular Inc | Device | Class II | 1 |
| 23 Mar 2015 | CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent | BD Biosciences, Systems & Reagents | Device | Class II | 1 |
| 23 Mar 2015 | Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,Sterile EO, Rx Only, Manufacturer Edwards Lifesciences LLC, Irvine, CA.-Model Numbers: FEMII008A, FEMII008AT, FEMII008V, FEMII010A, FEMII010AT, FEMII010V, FEMII012A, FEMII012AT, and FEMII012V. Edwards Femoral Access Cannulae are intended to… | Edwards Lifesciences, LLC | Device | Class II | 1 |
| 23 Mar 2015 | Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015,… | Medtronic Inc. Cardiac Rhythm Disease Management | Device | Class II | 1 |
| 23 Mar 2015 | ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 23 Mar 2015 | Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose with calcium) Injection, 2000 mL in Dual Chamber Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- Product code 2B7722, NDC 0338-1125-04 | Baxter Healthcare Corp | Drug | Class II | 2 |
| 23 Mar 2015 | Rising Moon Organics Garlic and Veggie Ravioli; Net Wt 8 oz. (227g) UPC 7 85030 00011 3 Distributed by Rising Moon Organics 313 Iron Horse Way Providence, RI 02908 | Carmel Food Group, Inc. | Food | Class II | 3 |
| 22 Mar 2015 | Packed in rigid plastic clam shell container: Giant Eagle Little Italy Panini Cold; Sell By: (all dates up to and including) 3/24/2015; PLU #97525; Net Wt 13oz; Contains Wheat, Milk, Fish (Anchovy); Keep Refrigerated ; Giant Eagle Little Italy Panini Hot; Sell By: (all dates up to and including) 3/22/2015; PLU: 7369;… | Giant Eagle, Inc. | Food | Class I | 1 |
| 22 Mar 2015 | Giant Eagle Japanese Breaded Cod Fillet various weights Contains: Fish, Wheat, Milk, Egg Dist. By: Giant Eagle Mkts. Co., Pittsburgh, PA 15238 Sell by: (up to and including) 3/26/2015 Sold on foam trays with flexible plastic overwrap. | Giant Eagle, Inc. | Food | Class I | 1 |
| 21 Mar 2015 | Nutiva O'Coconut Lightly Sweetened Coconut Treat - Classic Sold in 8 - x 0.5 oz. individually wrapped pieces, UPC 6-92752-10557-9 and Singles of 24 - 0.5 oz, per box - UPC 6-92752-10500-5. - 24 singles x 6 caddies per shipping case - 144 individual units. Certified Organic, Fair Trade Certified. Manufactured for:… | Nutiva | Food | Class I | 2 |
| 20 Mar 2015 | -Frozen IQF Chopped Organic Spinach Packed in Bulk in 1,000 lb tote bins Each tote bin is tagged with a label containing the following information, item number, lot code, production date, weight, and SKU number. 00SP0241T10 Organic Spinach Cut Leaf Lot # 1431930067 Quantity: 1 Net Weight: 1,000 lbs Prod Date… | Coastal Green Vegetable Company, LLC | Food | Class II | 4 |
| 19 Mar 2015 | Artis Q/ Q zen systems; Artis Q/ Q zen systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 19 Mar 2015 | GetGo Giant Eagle Strawberry Yogurt Parfait Sell By: (up to and including) 3/24/2015 Distributed by: Giant Eagle, Inc., Pittsburgh, PA 15238 Contains: Milk, Wheat, Almonds Net Wt: 10 oz. | Giant Eagle, Inc. | Food | Class II | 1 |
| 18 Mar 2015 | LOW PROFILE NON-LOCK SCREW; 2.7mm x 22 mm; REF 131227222; LOT RM105E. Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries. | Biomet, Inc. | Device | Class II | 1 |
| 18 Mar 2015 | Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites. | Hansen Medical Inc | Device | Class II | 1 |
| 18 Mar 2015 | 0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0049-03 | Baxter Healthcare Corp. | Drug | Class II | 2 |
| 18 Mar 2015 | Banana Langka Empanada (6.5 oz), 24 units/case, UPC 0 30283 16483 0 | A I Foods Corporation | Food | Class II | 7 |
| 17 Mar 2015 | Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Usage: The temporary pacemaker is used with a cardiac pacing lead system for temporary single or dual chamber pacing in a clinical environment by trained personnel. The temporary pacemaker can be used where short-term demand (synchronous) or… | Medtronic Inc. Cardiac Rhythm Disease Management | Device | Class II | 1 |
| 17 Mar 2015 | Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty 14g x 16cm (22mm), Product Code: 121416; Monopty Biopsy, Product Code: 000441; Monopty 14g x 10cm (22mm), Product Code: 121410; Monopty 14g x 10cm (11mm), Product Code: 211410. The BARD MONOPTY Disposable Core Biopsy Instrument is a single use core… | Bard Peripheral Vascular Inc | Device | Class II | 1 |
| 17 Mar 2015 | Kraft Macaroni & Cheese Boxed Dinner Original Flavor, 7.25oz.,packaged in blue and yellow cardboard box. There are four different package types affected by this recall: 1) single 7.25 oz boxes, 3-pack box of 7.25 oz boxes, 4-pack shrink wrap of 7.25 oz boxes, and 5-pack shrink wrap of 7.25 oz boxes. Event 70766 | Kraft Foods Group Inc. | Food | Class II | 1 |
| 16 Mar 2015 | Natus neoBLUE blanket LED Phototherapy system which includes the following items: 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with… | Natus Medical Incorporated | Device | Class II | 1 |
| 16 Mar 2015 | da Vinci S Surgical System IS2000, Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting. | Intuitive Surgical, Inc. | Device | Class II | 14 |
| 16 Mar 2015 | DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product Usage: The PRO-Trac II Tacrolimus ELISA kit is an in vitro reagent system intended for the quantitative determination of tacrolimus (Prografl, FK506) and some metabolites in human EDT A or heparinized whole blood as an aid in the management… | Diasorin Inc. | Device | Class II | 1 |
| 15 Mar 2015 | STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic. | Focus Diagnostics Inc | Device | Class II | 1 |
| 13 Mar 2015 | Integra Flowable Wound Matrix Size 3cc 1 unit/box single use, sterile device Rx Only Model Number FWD301 (US) & FDR301 (Non-US) Flowable Wound Matrix is comprised of the following components which are provided in a sealed and sterilized Tyvek / plastic tray: - An empty plastic syringe with Luer-Lok" tip - A plastic… | Integra LifeSciences Corp. | Device | Class II | 1 |
| 13 Mar 2015 | Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx Only, Teleflex Medical. | Teleflex Medical | Device | Class II | 1 |
| 13 Mar 2015 | Ebola IgX VP-40 Serum/Plasma/Blood Cassette, Catalog No. I-100 Materials Provided: 1. Test Device 2. Lancet 3. Alcohol pad. 4. Develop buffer tube contain buffer vial (0.3ml) | Lusys Laboratories, Inc. | Device | Class I | 8 |
| 13 Mar 2015 | Whole gutted haddock. Product was sold refrigerated in 100 pound fish totes. Event 70771 | Cape Ann Seafood Exchange, Inc. | Food | Class II | 1 |
| 13 Mar 2015 | Klaire Labs Ther-Biotic FACTOR 6 100+ Billion CFU's Multi-Species Probiotic Supplement 60 Vegetarian Capsules. UPC 7 09616 01248 2 Manufactured by ProThera Inc . Klaire Labs is a division of ProThera, Reno, NV. | ProThera, Inc. | Food | Class II | 2 |
| 12 Mar 2015 | Lineum HF Torque Handle Limit (Lineum) Model Number 14-525035 P_roduct Usage: Designed to facilitate reconstruction of the cervical and upper thoracic spine using bones screws, locking plugs, and various types of rods, hooks, and lateral connectors. | Biomet Spine, LLC | Device | Class II | 2 |
| 12 Mar 2015 | Alaris PC units, Model No. 8015. Infusion pump. | CareFusion 303, Inc. | Device | Class II | 1 |
| 12 Mar 2015 | Cinnamon Almonds, Net Wt. 16 oz, UPC # 00761437, 24 units per case | Trader Joes Company | Food | Class I | 1 |
| 12 Mar 2015 | BADIA Ground Cumin Event 70814 | Badia Spices, Inc. | Food | Class I | 1 |
| 11 Mar 2015 | INFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular intervention with fluoroscopic and fluorographic images. For the USA and Canada the system is registered as lnfinix CF-i or lnfinix VF-i, for national regulations. INFX-8000V series includes a floor mounted multi-axis… | Toshiba American Medical Systems Inc | Device | Class II | 1 |
| 11 Mar 2015 | Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, pedicle screw assemblies (screw, cap, yoke) and cross bar connector assemblies. | X Spine Systems Inc | Device | Class II | 1 |
| 11 Mar 2015 | Fexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor and Outdoor Allergies, Non-Drowsy, Original Prescription Strength, a) 60 count Bottles, NDC 0378-0781-91, b) 500 count Bottles, NDC 0378-0781-05, Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV, 26505, USA. | Mylan Pharmaceuticals Inc. | Drug | Class III | 1 |
| 11 Mar 2015 | Crown Confectionery Co. Corn Bba, Net Wt. 72g packed in Polypropylene, Manufactured by Crown Confectionery Co., Ltd. (Choong Chung Nam Do, S. Korea), UPC 8801111910743 Event 70709 | T Up Trading | Food | Class I | 1 |
| 11 Mar 2015 | Giant Eagle Irish Soda Bread, 16oz loaf, in plastic wrap, one 16oz loaf per wrapped package | Giant Eagle, Inc. | Food | Class I | 1 |
| 10 Mar 2015 | Brand Name: Persona Anterior Referencing Sizer with Locking Boom The Persona Anterior Referencing Sizer is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. The Persona Surgical Technique (97-5026-001-00, Rev. 9) states that the sizer helps ensure that the desired external… | Zimmer, Inc. | Device | Class II | 1 |
| 10 Mar 2015 | Talon Grasping Device, 160 cm, US endoscopy. Used for retrieval of foreign bodies, tissue specimens, stones or calculi in endoscopic procedures of the gastrointestinal tract. | US Endoscopy Group Inc | Device | Class II | 1 |
| 10 Mar 2015 | FREEDOMAIRE(R) HELMET SYSTEM WITH SUPER POWER PAK BATTERY, LUMBAR BELT AND MOTOR MODULE, REF 11110STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating environment and the surgical personnel in order to protect against… | Microtek Medical Inc | Device | Class II | 13 |
| 10 Mar 2015 | AIR COMPRESSED, Medical Air, USP, Rx Only. Matheson Tri-Gas, Inc., 150 Allen Road, Basking Ridge, NJ 07920. Available in A) E or 22 cu ft cylinder, NDC: 55037-302-09; B) 40 cu ft cylinder, NDC: 55037-302-10; C) 200 cu ft cylinder, NDC: 55037-302-15; D) 220 cu ft cylinder, NDC: 55037-302-16; E) 300 cu ft cylinder,… Event 70713 | Matheson, Inc. | Drug | Class III | 1 |
| 9 Mar 2015 | Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used to insert OsteoSponge SC grafts to fill bone defects in the subchondral region of articulating joints. The Instrument Kit is used to establish and maintain a port of entry for arthroscopic instruments or for an open procedure. The kit is… | Bacterin International, Inc. | Device | Class II | 1 |
| 9 Mar 2015 | Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems. | GE Healthcare | Device | Class II | 1 |
| 9 Mar 2015 | WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pinned Yoke - Part Number 900019-70; LL100 Multi Tip W/TC - Part Number: 900629; LL100 - CO2 - Part Number 900162 | CooperSurgical, Inc. | Device | Class II | 1 |
| 9 Mar 2015 | DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalangeal implant. | In2Bones, SAS | Device | Class II | 2 |
| 9 Mar 2015 | Replace Select Tapered TiU NP 3.5x10mm, Article No. 29401. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and… | Nobel Biocare Usa Llc | Device | Class II | 27 |
| 9 Mar 2015 | MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 9 Mar 2015 | Herbst Universal Nut which is used in a Herbst Appliance A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance. | Specialty Appliance Works, Inc. | Device | Class II | 10 |
| 9 Mar 2015 | GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T, SIGNA EXCITE 3.0T, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA Contour, Brivo MR355, Optima… | GE Healthcare | Device | Class II | 1 |
| 9 Mar 2015 | Fomepizole Injection, 1.5 g/1.5 mL (1 g/mL), For Intravenous Infusion only, Rx only, Manufactured by: Emcure Pharmaceuticals Lt. for Sandoz Inc., Princeton, NJ 08540, NDC 0781-3182-73 and 0781-3182-84 Event 70752 | Navinta LLC | Drug | Class II | 1 |
| 9 Mar 2015 | Wu Fu Yuan New Sago Taro, Net Wt: 8.8oz. (250g), Manufactured by: Shanghai Yuan Zhen Food Co., Ltd, 4968-2, UPC 6927055989033 | Walong Marketing, Inc. | Food | Class II | 1 |
| 9 Mar 2015 | Yang Sheng Preserved Egg (Long-Lansing Duck Egg), each box contains 6 preserved eggs, each box weighs about 12 ounce (340g), Manufacturer: Ya Nong Co., Ltd, No. 181-1, Singdong Rd., Jhongli City, Taoyuan County, 320, Taiwan R.O.C., Product of Taiwan | Summit Import Corporation | Food | Class II | 1 |
| 6 Mar 2015 | YC-1800 OPHTHALMIC YAG LASER SYSTEM; The YC-1800 allows the safe and bloodless treatment of intraocular diseases for outpatients by mechanical disruption caused by energy of the YAG laser pulses. | Nidek Inc | Device | Class II | 1 |
| 6 Mar 2015 | BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use. | BD Biosciences, Systems & Reagents | Device | Class II | 1 |
| 6 Mar 2015 | CROSSCHECK(R) Plating system, HOCKEY STICK CX Plate, Left, REF CCP-HSX1L. Orthopedic use. | Wright Medical Technology, Inc. | Device | Class II | 19 |
| 6 Mar 2015 | Stop & Shop Clear Splash Orange Mango, 1 liter plastic bottle Flavored Sparkling Water Beverage Distributed by Foodhold U.S.A., LLC Landover, MD 20785 UPC Codes: 6-882677-14066 Event 70674 | Polar Corp. | Food | Class II | 1 |
| 6 Mar 2015 | Shanghai Ceramic Spoons; SKU 487874; UPC 2487874 Event 70570 | Cost Plus Management Services, Inc. | Food | Class II | 1 |
| 6 Mar 2015 | Mrs. Fields White Chunk Macadamia Cookies; 12 individually wrapped cookies in a tray/box; there are 6 trays/boxes to a case. Therefore there are 72 cookies in a case; 2.1 oz single size serving. Event 70699 | Interbake Foods Llc | Food | Class II | 1 |
| 5 Mar 2015 | Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00. This kit is for Spacelabs Healthcare Blease 700/900 Series Ventilators. Designed specifically for the mechanical ventilation of adult and pediatric patients under general anesthesia. | Del Mar Reynolds Medical, Ltd. | Device | Class II | 1 |
| 5 Mar 2015 | SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Rod Caliper is a manual surgical instrument that may be used as part of the PedFuse Pedicle Screw System and its MISquito components during percutaneous, minimally invasive surgical (MIS) technique of posterior… | SpineFrontier, Inc. | Device | Class II | 1 |
| 5 Mar 2015 | Sony Medical Monitor LMD-1951MD 19 inch Event 70702 | Sony Latin America | Device | Class II | 1 |
| 4 Mar 2015 | RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RayStation 4.7, the issue applies also to machines with fixed jaws, regardless of MLC/jaw position. RayStation is a software system designed for treatment planning and analysis of… | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 4 Mar 2015 | Hardy Diagnostics cat no. G327 HardyCHROM SS Agar (HardyCHROM Salmonella Shigella) Cat no: G327 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2 to 8 degrees C. on receipt in dark A selective chromogenic medium for the primary screening isolation, and differentiation of Salmonella & Shigella… | Hardy Diagnostics | Device | Class II | 1 |
| 4 Mar 2015 | Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions. | Cardiovascular Systems, Inc. | Device | Class I | 1 |
| 3 Mar 2015 | da Vinci Xi Surgical System, IS4000; Assy, Distal SUJ, Inner, IS4000 Material number: 380662-20 and 380662-21. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endocopic Instruments including rigid… | Intuitive Surgical, Inc. | Device | Class II | 3 |
| 3 Mar 2015 | Stonewall Kitchen Buffalo Wing Sauce Net Wt. 17.5 oz. glass jar UPC 711381-31395 4 Item # 251805, | Stonewall Kitchen, LLC | Food | Class II | 1 |
| 2 Mar 2015 | Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion System (Pump) version 8.0, Product Code 35700BAX2 The SIGMA Spectrum Infusion Pump with Master Drug Library (MDL) is intended to be used for the controlled administration of fluids. | Baxter Healthcare Corp | Device | Class II | 1 |
| 27 Feb 2015 | GE Healthcare, Aespire 7900, Aespire View Anesthesia Machines. Model numbers 1009-9012-000. Intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients | GE Healthcare | Device | Class II | 1 |
| 27 Feb 2015 | Talenti Gelato & Sorbetto, 1 pt. (473 mL) in clear plastic jars with best by date 5/19/2016, UPC 8685200024 | Unilever United States, Inc. | Food | Class I | 1 |
| 27 Feb 2015 | Nicomex Candy Mex, Productos Mexicanos, Distributed by Nicomex, Inc., 88 First Street, Passaic, NJ 07055 | Nicomex Inc. | Food | Class I | 1 |
| 27 Feb 2015 | Frozen vegetable-based burgers RETAIL - DOMESTIC: Organic Sunshine Burgers Gluten Free Soy Free Vegan Barbecue 3 Organic Veggie Burgers Keep Frozen Net WT: 8 OZ. Best Before: 5/4/16; 6/11/2016; 8/13/16; CANADIAN: Organic Sunshine Burgers Barbecue 3 Organic Veggie Burgers Galettes Veggie biologiques Keep Frozen/Garder… | Sunshine Burger & Specialty Food Company, LLC | Food | Class II | 3 |
| 26 Feb 2015 | Vitagel; indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. | Orthovita, Inc., dBA Stryker Orthobiologics. | Device | Class II | 1 |
| 26 Feb 2015 | The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelligence to continuously adapt to the user’s walking style and environment. The RHEO KNEE recognizes and responds immediately to changes in speed, load and terrain, restoring the user’s… | Ossur H / F | Device | Class II | 1 |
| 26 Feb 2015 | CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover with attached (3 cm) NeoGuard tip, REF 610-833. Each cover is packaged in a Tyvek pouch with accessories of gel and fasteners. Individual Tyvek pouches are packaged as a box of 12. Rx only. The cover allows use of the… | Civco Medical Instruments Inc | Device | Class II | 1 |
| 26 Feb 2015 | LIS27T - Lacrimal Intubation Set RX Only Sterile Used in various ophthalmology procedures. | Quest Medical, Inc. | Device | Class II | 1 |
| 26 Feb 2015 | ToggleLoc; fastener, fixation, non degradable, soft tissue; Artificial Ligament Fixation Device #7 PE Ziploop Extended Toggleloc Product Usage: The Toggleloc System is a non-resorbable system intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation, due to injury or… | Biomet, Inc. | Device | Class II | 2 |
| 26 Feb 2015 | Cheryl's Buttercream Frosted Cut-Out BUNNY HEAD COOKIES, Net Wt 1.5oz (43g), Cheryl's Westerville, Ohio 43082 www.Cheryls.com ALLERGEN STATEMENT: Contains Wheat, Soy, Milk and Eggs. Produced in a plant that also handles peanuts and tree nuts. Event 70663 | Cheryls | Food | Class III | 1 |
| 26 Feb 2015 | Mrs. T’s Pierogies, Net Wt 16 oz (1 lb) 456 g,12 Pieces/ Carton 12 Cartons/ Case, frozen, Best By: 05/20/16, 07/15/16, 08/27/16 UPC: 4116400042 Event 70624 | Ateeco, Inc. | Food | Class II | 1 |
| 25 Feb 2015 | Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae. | Biomerieux Inc | Device | Class III | 3 |
| 25 Feb 2015 | Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainage Catheter and APDL Drainage Catheter Kit, Expel" Drainage Catheter APD Drainage Catheter, Expel" Large Capacity Drainage Catheter APD Large Capacity Drainage Catheter. | Boston Scientific Corporation | Device | Class II | 1 |
| 25 Feb 2015 | Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits | Boston Scientific Corporation | Device | Class II | 1 |
| 25 Feb 2015 | Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers). Event 70710 | Captiva Spine, Inc | Device | Class II | 1 |
| 25 Feb 2015 | Minivelle (estradiol transdermal system) 0.05 mg/day, 8-count box, Rx only, Manufactured by Noven Pharmaceuticals, Inc., Miami, Florida 33186, Distributed by Noven Pharmaceuticals, LLC, Miami, Florida 33186, NDC 68968-6650-8 | Noven Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 25 Feb 2015 | Gourmet Foods Mamma-Italia Traditional Italian Raw Pizza Dough Ball, Box Quantity: 30 16 oz BALL Keep Frozen NET WT: 30 lbs (13.61Kg), Ingredients: Wheat Flour***Dough Conditioner (Whey, Corn Flour***). Mamma_Italia Brunswick OH 866.368.4446 MAMMA-ITALIA.COM 8 95548 00213 1 | Dough Acquisition Co | Food | Class I | 2 |
| 25 Feb 2015 | Horchata Post Mix Fountain Syrup, 3 gallons (11.4 Liters), UPC 0 09319 00006 0. Event 70631 | Fiesta Pacific Products Inc. | Food | Class II | 1 |
| 24 Feb 2015 | Skintact ECG Electrode FS-50, Catalog no. 58028 , & Stable Base ECG Electrode SBT-60, Catalog no. 50547. To acquire and transmit the electrical signal at the body surface to a processor that produces an electrocardiogram (ECG) or vectorcardiogram. | Leonhard Lang Medizintechnik GmbH | Device | Class II | 1 |
| 24 Feb 2015 | Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused. | Synthes, Inc. | Device | Class II | 1 |
| 24 Feb 2015 | QuikLYTE Dilution Check: used to monitor and adjust for the dilution ratio on Dimension clinical chemistry systems with the QuikLYTE module. Intended Use of the QuikLYTE module : The Na+, K+, Cl and TCO2 methods on the Dimension clinical chemistry system with the QuikLYTE module are in vitro diagnostic tests intended… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 24 Feb 2015 | Droperidol injection, 2.5 mg/mL, 5 mg Total Dose, 2 mL Fill Volume per syringe, packaged in 10-count syringes per heat sealed bag, RX only; Compounded for Office Use by SCA Pharmaceuticals, Little Rock, AR (877 ) 550-5059 Bar Code 88888-7720-16 | SCA Pharmaceuticals | Drug | Class II | 1 |
| 24 Feb 2015 | Healthy Mama Boost it Up Mango with Ginger Caffeine Free Protein with Energy Drink 12 fl oz Distributed by: Maternal Science, Inc. 50 Tice Boulevard, Suite 340 Woodcliff Lake, NJ 07677 UPC 810758020058 | Maternal Science Inc | Food | Class I | 3 |
| 23 Feb 2015 | RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation. | DePuy Orthopaedics, Inc. | Device | Class II | 1 |
| 23 Feb 2015 | Twin Tree Gardens Premium Rubs "bunkhouse" Chicken Rub, Net Wt. 2.75 oz. (77g), Distributed by: Flavor Delight, Inc., Richburg, South Carolina, UPC 041278582362 Event 70728 | Haddon House Food Products Inc | Food | Class II | 1 |
| 23 Feb 2015 | Crown Naturals Trail Mix, Net Wt. 9 oz. (7.80 LB), Sale by: 10/9/2015, Product of USA, Packed by Crown Food, North Bergen, NJ 07047 Event 70626 | Crown Food Distributor Inc. | Food | Class II | 1 |
| 20 Feb 2015 | GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM. Catalog number GAP-N48-16; GAP-N48-18; GAP-N48-26; GAP-N48-28. Product Usage: The GAP Endo-Exo Medullary System is used for the treatment of fractures or correction of deformities in the femur, tibia and humerus of pediatric patients, who have… | Pega Medical Inc. | Device | Class II | 1 |
| 20 Feb 2015 | Coblator II System, 120V. Product Usage: The Coblator II (Model RF8000E) is a bipolar, radiofrequency electrosurgical system designed for use in otorhinolaryngology (ENT) surgery. The system consists of the following components: an electrosurgical radiofrequency controller, a reusable, non-sterile Power Cord; a… | ArthroCare Medical Corporation | Device | Class II | 1 |
| 20 Feb 2015 | OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US). Product Usage: Indicated for use in patients undergoing cataract surgery for removal of crystalline lens. | Abbott Medical Optics, Inc. | Device | Class II | 1 |
| 20 Feb 2015 | Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured by Titan Spine, LLC. Endo TCS driver is one of the instruments within the surgical tray for use with the Interbody Fusion Device(IBD). | TITAN SPINE, LLC | Device | Class II | 1 |
| 20 Feb 2015 | Organic Horizon Sandwich Crackers Cheddar, 7.5 oz packages, 12 boxes per case. Event 70572 | White Wave Foods, Inc | Food | Class I | 1 |
| 20 Feb 2015 | SAZON IBERIA CON CULANTRO Y ACHIOTE Coriander & Annatto: 1) NET WT. 3.52 OZ. 100g, 18/20 PACKS, UPC 0 75669 10832 9, 2) NET WT. 6.34 OZ. 180g, 15/36 PACKS, UPC 0 75669 10831 2 | Iberia Foods Company of New York, Inc | Food | Class II | 2 |
| 20 Feb 2015 | Cocola Macaroons; Each box contains 5 flavors (3 ct each): Mango Passion, Raspberry, Pistachio, Coffee, and Chocolate. Net wt. 7 oz. ; UPC 091037037985. Ingredient: Fresh Egg White, Mango Puree, Passion Fruit Puree, Granulated sugar, powdered sugar, Almond Flour,Butter N&A color, coffee extract, sour cream, cream,… Event 70569 | Cocola INC | Food | Class II | 1 |
| 20 Feb 2015 | HAZELNUTS (FILBERTS), varying weights up to 16 oz., Item Code 228119 XXXXXX --- PACKAGED BY FAIRWAY MARKET, 2284 12TH AVENUE, NEW YORK, NY 10027 --- The product is packaged in clear, plastic cello bags of varying weights, each weighing less than one pound. Item Code 228119 XXXXXX (last six digits vary due to weight… Event 70567 | Fairway Operating Corp. | Food | Class I | 1 |
| 20 Feb 2015 | 8 in. sundried tomato flavored tortilla wraps, packaged in re-sealable polypropylene bags, 10 wraps per bag. Sold under the El Popocatepetl brand name. | El Popocatepetl Ind., Inc. | Food | Class I | 3 |
| 19 Feb 2015 | BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson Infusion Therapy Systems Inc. An accessory to an intravascular administration set that permits injection, gravity flow or withdrawal of fluids. | Becton Dickinson & Company | Device | Class II | 1 |
| 18 Feb 2015 | Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 18 Feb 2015 | Haloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-409-00) packaged in cartons of five (NDC 67457-409-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103 | Mylan Institutional LLC | Drug | Class II | 2 |
| 18 Feb 2015 | KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside an amber glass bottle, packaged by RemedyRepack, Indiana, PA, mfg by Hospira, Inc. Lake Forest, IL NDC 61786-0055-01 | RemedyRepack Inc. | Drug | Class II | 1 |
| 18 Feb 2015 | IMPORTED DRY MUSHROOMS, bulk box 30 lbs, distributed by Kirsch Mushroom Co. Inc., 751 Drake St., Bronx, NY 10474 (labeling for bulk product not provided by NYSDAM) --- Repacked product: IMPORTED DRY MUSHROOMS, WEIGHT XXX - SLOAN SUPERMARKET 494 REIMAN STREET SLOAN, N.Y. 14212 --- The mushrooms were sold in a bulk… Event 70560 | Kirsch Mushroom Co. Inc | Food | Class I | 1 |
| 18 Feb 2015 | Organic Chocolate Hazelnut Butter with Fair Trade 65% Dark Chocolate, Item no. N270. Product is sold under Hummingbird brand, packaged in 1 lb. (454 gram) glass jar with white metal lid. The UPC is 6-96859-11035-1. | Hummingbird Wholesale | Food | Class I | 1 |
| 17 Feb 2015 | Double Swivel Connector with Suction Port Connector, Airway (Extension) King Systems part 7169 Product Usage: An airway connector is a device intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or gas mask. The double swivel connector with suction port is an optional connector for a… | King Systems Corp. | Device | Class II | 1 |
| 17 Feb 2015 | Ground Cumin. 16 oz. Oz Qt Spice Jar Event 70541 | Imported Foods Resource Group, Inc. | Food | Class I | 1 |
| 16 Feb 2015 | ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures.. | Brainlab AG | Device | Class II | 1 |
| 16 Feb 2015 | Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable Angle Locking Peg, D:1.8mm x L:18.0mm; Variable Angle Locking Peg, D:1.8mm x L:20.0mm; Variable Angle Locking Peg, D:1.8mm x L:22.0mm, Variable Angle Locking Peg, D:1.8mm x L:24.0mm; Variable Angle Locking Peg,… | Flower Orthopedics Corporation | Device | Class II | 1 |
| 16 Feb 2015 | Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL) 25 x 5 mL Single Dose Vials, For Intravenous or Intramuscular Use, Preservative Free, Rx Only, Manufactured by: West-Ward Pharmaceuticals, Eatontown, NJ 07724, NDC 0641-6028-25. Event 70548 | West-Ward Pharmaceutical Corporation | Drug | Class III | 1 |
| 16 Feb 2015 | Breyers No Sugar Added Salted Caramel Swirl 1.5-quart (1.41L) packaged in paperboard tubs Unilever, Englewood Cliffs, NJ 07632 USA Unit UPC: 7756738393. Product sold as 1.5-quart (1.41L) paperboard tubs, delivered to retailers in shrink wrap. Case UPC: 10077567383935 | Unilever United States, Inc. | Food | Class I | 1 |
| 13 Feb 2015 | Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component. | Exactech, Inc. | Device | Class II | 1 |
| 13 Feb 2015 | Intraocular Lens (IOL), Part No. EC-3 PAL, Diopter: 17.5, 18.0, 18.5, 19.0, 19.5, 21.5, 23.5, 9.0, 22.5, 23.0, 21.0, 24.0. The device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed. Aaren… Event 70557 | Aaren Scientific, Incorporated | Device | Class II | 1 |
| 13 Feb 2015 | Natural Shaped Fried Egg (patties), 1.75 oz. frozen egg patties, packaged 144-count per case, Net WT. 15.75 lb. (7.14 KG), under two brand names: (1) Pappetti's Table Ready, UPC Code 46025 85879. The responsible firm name on the label is Michael Foods Inc., Minnetonka, MN 55305; and (2) Glen view Farms IQF, UPC Code… | Michael Foods, Inc. | Food | Class II | 1 |
| 13 Feb 2015 | Whole Foods Market Divine Treasures 100000 Smooches, Vegan Chocolate packaged in a clear round 8 oz plastic container, various weights | Whole Food Market | Food | Class I | 1 |
| 13 Feb 2015 | MR. HYDE INTENSE ENERGY PRE WORKOUT, Green Apple Natural and Artificial Flavor Dietary Supplement Net Weight 8.0 OZ (228 grams) | ProSupps USA LLC | Food | Class II | 1 |
| 13 Feb 2015 | Whole Foods Market "Chocolate Cake for Two" UPC code: 246357004999 Net Wt. 11 oz (0.69lb) in a clear plastic "clam shell" container. PLU#46357 | Whole Food Market | Food | Class I | 1 |
| 12 Feb 2015 | Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouches with Tyvek header (9.5 x 13.63 x 3.75") within a secondary corrugated shipper (16 x 11.02 x 5.12" inner dimensions). The device is indicated for assisted expression of milk using manual suction. | Ameda, Inc. | Device | Class II | 2 |
| 12 Feb 2015 | Bromfenac Ophthalmic Solution 0.09%, Rx Only. Mfg For: Apotex Corp., Weston, FL, 33326. Available in a) 1.7 mL Bottle, NDC: 60505-0595-5; b) 2 x 1.7 mL Bottles, NDC: 60505-0595-6; c) 2.5 mL Bottles, NDC: 60505-0596-4. | Apotex Inc. | Drug | Class III | 1 |
| 12 Feb 2015 | Assorted Milk Chocolate Royal Icing Pops sold as Assorted Character Icing Pops, Christmas Icing Pops, and Triple Heart Icing Pops, 24 pops per box. The Milk Chocolate Icing Pops are made to order and sold in unmarked bulk boxes. Each Milk Chocolate Icing Pop is individually wrapped for retail sale in 2 oz. clear… Event 70543 | Chocolate By Design, Inc. | Food | Class I | 1 |
| 11 Feb 2015 | ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Version 1.0.2, Siemens Material Number 11219493, IVD. The ADVIA XPT Chemistry System is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes at a throughput… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 11 Feb 2015 | Hellas Golden Double Smoked Herring Vacuum Karagounis Bros SA -Hellas -35 A.3 - C.E. 2nd Industrial Zone -37500 VOLOS TEL.: +30 24250 22018 - FAX : +30 24250 23747 Imported in USA by: Moscahlades Bros. Inc. 27 East 33rd St Paterson, NJ 07514 USA PH.: 973 881 1960 FAX: 973 881 1962 packaged in a carton approximately… Event 70521 | Moscahlades Bros Inc | Food | Class I | 1 |
| 11 Feb 2015 | Organic Sacha Inchi Powder, 8oz. white poly bags, UPC 803813-28444 1. Organic Sacha Inchi Powder, bulk. Event 70505 | Name withheld | Food | Class II | 1 |
| 11 Feb 2015 | Natural Grocers brand Organic Garlic Powder. Natural Grocers brand Organic Garlic Powder. Packaged in Zip-Lock-type plastic bags, labeled by random weight, average 0.28 lb. per package, distributed in 25 lb. cases. Packed by Vitamin Cottage Natural Grocers, Inc., Lakewood, CO. | Vitamin Cottage Natural Food Markets, Inc. | Food | Class I | 1 |
| 10 Feb 2015 | Walnuts Halves & Pieces Net Weight 16-oz 454.0 Grams UPC: 0078264065165 Hines Nut Company Dallas, Texas 75201; Walnuts Halves & Pieces Net Weight 12-oz 340.5 Grams UPC: 0078264065127 Hines Nut Company Dallas, Texas 75201; Harris Teeter Farmers Market Walnut Meats Net Weight 10 OZ. (284g) UPC: 072036881144 | Hines Nut Co | Food | Class I | 1 |
| 6 Feb 2015 | See's Candies Classic Red Heart with Assorted Chocolates (8 oz. 227 g), 42 hearts per carton; UPC 737666091201 Ingredients: Sugar, Cream, Chocolate , Cocoa Butter, Corn Syrup, milk, brown sugar, butter, honey, egg whites, molasses, salt, gelatin, vanilla, baking soda, hydroxylated soy lecithin, (an emulsifier),… | See's Candies Inc. | Food | Class I | 1 |
| 6 Feb 2015 | Pacific Coast Selections Stuffed Mushrooms; Net Wt. 7 oz. (198g) Best if sold by: 02/13/15 GHCA036 A16; UPC 0.98487-10131.0 Cooking Instructions: Place mushrooms on baking sheet and bake for 10-12 minutes until heated through and beginning to brown. GH Foods CA, Sacramento, CA 95828 | GH Foods CA LLC | Food | Class II | 1 |
| 6 Feb 2015 | UNCLE BEN'S(R) Ready Rice(R) ROASTED CHICKEN FLAVORED with Carrots and Herbs, Net Wt 8.8 oz (250 g), | Mars Food US | Food | Class II | 5 |
| 5 Feb 2015 | Medcomp Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III; AngioDynamics product- Dura-Flow Catheter, Schon XL Catheter; The affected product are insertion kits used to implant the devices packaged-long and short term… | Medical Components, Inc dba MedComp | Device | Class II | 1 |
| 5 Feb 2015 | Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128 & Ingenuity CT), Philips Medical Systems, Cleveland, OH | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 5 Feb 2015 | Vital Wheat Gluten Agridient, 50 lb. paper sack Event 70595 | Agridient, Inc. | Food | Class I | 1 |
| 4 Feb 2015 | NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only. Product Usage: Intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution-Rotating Hinge Knee (RHK)… | Zimmer Trabecular Metal Technology, Inc. | Device | Class II | 1 |
| 4 Feb 2015 | SutharIndia, Capsule | Health One Pharmaceuticals Inc | Food | Class II | 147 |
| 2 Feb 2015 | Austin Grand Prize Green Salsa; 1st Runner-up Texas Hot Sauce Challenge 1992; Mfg. Exclusively for: Skins N More Inc. 805 E. Court St., Suite #160 Seguin, Texas 78155 (210) 889-2109 | Creative Foodworks, Inc | Food | Class II | 52 |
| 30 Jan 2015 | Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EX-Lok Sampling; Product Code 154006: Lot # NGYJ0603 and NGYJ1671 | C.R. Bard, Inc. | Device | Class II | 1 |
| 30 Jan 2015 | Penner Patient Stretcher/Transfer Lift System Models 391000-1 and 392000-1 The Pacific Stretcher/Transfer Lift is used with Whirlpool or Aqua-Aire (air bubbling) bathing system intended for use in nursing homes, hospitals, and assisted living facilities to transfer and/or lift patients under the direct supervision of… Event 70151 | Penner Mfg Inc | Device | Class II | 1 |
| 30 Jan 2015 | Joseph's Mini Whole Wheat Pita, labeled as 100% STONE GROUND Whole Wheat Bread NET WT. 8 OZ (227g), UPC 074117000420. Product is packaged in a plastic bag. | Middle East Bakery, Inc. | Food | Class I | 10 |
| 29 Jan 2015 | ALOHA VANILLA PREMIUM PROTEIN is a powder and product is packed as the following: 1) Tin: UPC 641061842606, 2) Pouch: UPC 641061842644 and 3) Protein Tower 14 pack: UPC 640864820729. Formulated, Quality Tested & Exclusively Sold by ALOHA, Inc. NY, NY 10011 +1 888.444.3898 | Aloha | Food | Class II | 3 |
| 28 Jan 2015 | GROUND CUMIN, Net Wt. 5 lbs (2.3 Kg), UPC 7 52186 82560 0. Event 70407 | Sahadi Fine Foods, Inc. | Food | Class I | 1 |
| 28 Jan 2015 | RED THREAD FISH, NET WT: 7 OZ (200g), UPC 6 946976 817904, PRODUCT OF MYANMAR -- PACKED FOR; S W TRADING CO. HONG KONG --- The product was packed in a heat-sealed plastic bag. Event 70399 | Arcadia Trading | Food | Class I | 1 |
| 28 Jan 2015 | Cumin Ground, 2.75 oz., UPC: 811267012008. Product is packaged in a plastic bottle with a black flip-top lid. | The Spicemill LLC. | Food | Class I | 2 |
| 26 Jan 2015 | Price Rite Ground Cumin, Net Wt. 3 oz, UPC 041190761135 | Colonna Brothers Inc. | Food | Class I | 3 |
| 23 Jan 2015 | Bio-PLASTY Cannula (Needle) | Biologic Therapies, Inc | Device | Class II | 3 |
| 23 Jan 2015 | KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3795-01 --- Also labeled under NOVAPLUS label NDC 0409-3795-49 | Hospira Inc. | Drug | Class II | 2 |
| 23 Jan 2015 | The label reads in part "Christ Kitchen *** Blameless Blondies*** Net Weight: 15 oz (425gm). Product is a dry bakery mix and is packaged in a flexible plastic bag within a corrugated cardboard sleeve. Event 70454 | Christ Kitchen | Food | Class I | 1 |
| 23 Jan 2015 | LBL reads in part:*** AL'S PICADERA*** MANTENGASE REFRIGERADO ENTREMESES & POSTRES*** 3 LECHES***" Event 70346 | Name withheld | Food | Class I | 1 |
| 22 Jan 2015 | 1lb mungbean sprouts 15 box (20 bags a box) a week. 10lb mungbean sprouts 30 bag a week. These products are labeled as produced by Henrys Farm Inc | Henrys Farm Inc. | Food | Class I | 2 |
| 21 Jan 2015 | Adkins Barbecue Spice Net Wt. 25 lbs. UPC: 0-77139-21382-3 Event 70343 | American Spice & Seasoning, Inc | Food | Class I | 1 |
| 20 Jan 2015 | 0.9% Sodium Chloride Injection, USP, 250 mL, Rx Only, Hospira Inc., Lake Forest, IL, 60045, USA, NDC 0409-7983-02 | Hospira Inc. | Drug | Class I | 1 |
| 19 Jan 2015 | ADVIA Chemistry Systems Drug Calibrator I; For in vitro diagnostic use in the calibration of Phenobarbital_2 (PHNB_2), Phenytoin_2 (PHNY_2), and Theophylline_2 (THEO_2) methods on the ADVIA Chemistry systems. System Information: (For Information Only) The ADVIA Chemistry systems are automated, clinical chemistry… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 15 Jan 2015 | 6" Trifurcated Extension Set, Product Code: AMS-375-1 Accessory device used to administer medical fluids | Churchill Medical Systems, Inc. | Device | Class II | 12 |
| 15 Jan 2015 | Dark Chili Powder packaged in the following configurations: (1) a 5 by 7 in clear square bag with a zipper seal and a label weight of 2.24 oz (63.5 g), Distributed by The Fresh Market, Greensboro, NC, and (2) 4 oz clear square glass bottle with a silver metal cap and a label weight of 1.85 oz (52.4 g), Distributed by… | Brinkhoff & Monoson Inc | Food | Class I | 3 |
| 15 Jan 2015 | garden lites Southwestern Souffle, NET WT 7 oz (198g), UPC 7-04863-01720-4 | classic cooking llc | Food | Class I | 5 |
| 14 Jan 2015 | Culinary Masters, SCHWARMA SPICE BLEND 1/50 LB, Shelf Life: 180 days. | Gourmet Foods International | Food | Class I | 33 |
| 14 Jan 2015 | BAM124 Chili Powder Salt Free | Starwest Botanicals, Inc | Food | Class I | 5 |
| 13 Jan 2015 | cobas EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay | Roche Molecular Systems, Inc. | Device | Class III | 1 |
| 13 Jan 2015 | GE Inspection Technologies x|tome|x L240 an Cabinet X-ray system | GE Inspection Technologies, LP | Device | Class II | 2 |
| 13 Jan 2015 | Honey & Oat Mixers ready-to-eat dry cereal sold under the market pantry brand and packaged in card stock cartons with a new weight of 18 oz. (1 lb. 2 oz.) 510 g. | Gilster-Mary Lee Corp. | Food | Class I | 1 |
| 12 Jan 2015 | Whole Foods Salted Caramel Crispies Cookies, 12 pack packaged in cellophane with tie closure | Whole Food Market | Food | Class II | 1 |
| 12 Jan 2015 | NATURAL EARTH PRODUCTS, NATURAL EARTH SPICES Ground Cumin, 5 lb. Natural Earth Products Brooklyn, NY 11207. Event 70269 | Natural Earth Products | Food | Class I | 1 |
| 12 Jan 2015 | My Spice Sage CUMIN GROUND under the following labels and packaging: 1) NET WT 1 oz (28g) UPC 00105001, packed in a plastic resealable bag 2) NET WT 4 oz (113g) UPC 00105004 packed in a plastic resealable bag, 3) NET WT 4.9 oz (139g) UPC 00105000 packed in a plastic bottle, 4) NET WT 16 oz (454g) UPC 00105016 packed… Event 70243 | Zenobia Company LLC | Food | Class I | 1 |
| 12 Jan 2015 | H-E-B Single Serving Tortilla Soup 8 oz. and 16 oz. and purchased from the hot soup kettle at the Deli/Prepared Foods Counter purchased on or before 01/06/2015 | H-E-B Houston Culinary Center | Food | Class I | 4 |
| 9 Jan 2015 | Ground Cumin, Net Wt: 5 LBS (2.25KG) Best By: 09/10/2016, Product of Turkey, Packed By: Vintage Food Corporation, 849 Newark Tpke, Kearny, NJ 07032, UPC 603608270037 | Vintage Food Corp. | Food | Class I | 1 |
| 9 Jan 2015 | NuSpice Taco Seasoning - F4422 D, Net Wt: 48 lb packed 8/ 6 lb bags, Manufacturer: Nu Products Seasoning co., 74 Louis Court, South Hackensack, N.J. 07606 | Nu Products Seasoning Co. | Food | Class I | 2 |
| 9 Jan 2015 | Mild Salsa, 14 oz; product is packaged in clear plastic tub with plastic lid, labeled in part, "***SAN JUAN SALSA CO.***MILD***Keep Refrigerated***NET WT. 14 oz (397 g)***SAN JUAN SALSA CO. 5919 195TH ST. NE #5, ARLINGTON, WA 98223***" UPC code: 7 18738 54632 4 | San Juan Salsa Co. | Food | Class II | 6 |
| 9 Jan 2015 | farm to table meals : Lentil and Barley. This is a dried soup/chili mix which contains lentils and barley in a large zip lock plastic bag along with a small zip lock bag of a chili spice packet. The spice packet contains the recalled cumin. Each plastic zip lock bag has a label affixed to it. The outer label is… Event 70520 | Food for Lane County | Food | Class II | 1 |
| 9 Jan 2015 | Taj ETHNIC GOURMET BOMBAY CURRY Simmer Sauce, NET WT 16.0 OZ. (454.0g), UPC 7 18687 30010 7 | The Hain Celestial Group- Worldwide Headquarters | Food | Class II | 3 |
| 9 Jan 2015 | HEB Bean & Cheese Dip 9 oz. UPC: 041220804016 | Dursett Amigos, Ltd | Food | Class II | 11 |
| 8 Jan 2015 | CS 8100, CATALOG # (s): 5303045, 5311129, 5303060, 5303110 Intended to produce complete or segmented tomographic digital panoramic X-ray images to be used at the direction of healthcare professionals of the dento-maxillo-facial region of the human anatomy as diagnostic support for pediatric and adult patient. | Carestream Health, Inc. | Device | Class II | 2 |
| 8 Jan 2015 | Frozen Shredded Pork Enchilada Meal; Heat sealed frozen dinners,16 oz and 29.6 oz UPC for 16 ounce small is 12859007998, and UPC for 29.6 ounce large is 12858013990 | Market of Choice Inc. | Food | Class II | 3 |
| 8 Jan 2015 | Single serving pie, 7 oz., is packed in a black paper cup with clear plastic lid, with white Sour Cream Lemon sleeve label. Product is labeled in part, "***Winn Dixie bakery PIE Sour Cream Lemon Pie***NET WT. 7 oz. (198 g.)***Distributed by Winn-Dixie Stores Jacksonville, FL 32254***" UPC: 0 21140 00083 5 Event 70242 | Fresh Foods Of America, Llc | Food | Class II | 1 |
| 7 Jan 2015 | Chef's Delight Spices & Herbs - Ground Cumin, Net Wt. 5.0 lb Jugs, Packed for Hermolia, Packed by CO, Brooklyn, NY Event 70566 | Prima Spice, Inc. | Food | Class I | 1 |
| 6 Jan 2015 | Benzonatate Capsules, USP, 100 mg, 100 count (10X10), Rx only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217 --- NDC 68084-214-01(carton) NDC 68084-214-11 (individual dose) | American Health Packaging | Drug | Class II | 1 |
| 6 Jan 2015 | Practi-0.9% Sodium Chloride, 50 mL, 100 mL, 250 mL, 500 mL, and 1000 mL bags, Product of China, Wallcur, San Diego, CA, 92111, USA; Wallcur Practi Products for Clinical Simulation; NDCs 5108-0954-75, 5108-0954-71, 5108-0954-72, 5108-0954-74, 5108-0954-73. Event 70155 | Wallcur Incorporated | Drug | Class I | 1 |
| 6 Jan 2015 | Ground Cumin, sold under Aunt Patty's brand, packed in 1lb. pack, 5 lb. pack, 25 lb. pack, and 50 lb. pack. Product is labeled in part, "***Handled in a facility that processes and/or repacks peanuts, soy, wheat, tree nuts, and dairy products.***" Item #12650 is for 1 lb. Item #12648 is for 5 lb. Item #12651 is for… | GloryBee Inc | Food | Class I | 3 |
| 5 Jan 2015 | Cumin Powder (comino molido) Various brands: 1) Key Food Quality Natural Spices , NET WT. 12 oz., UPC 073296001440; 2.)La Mina" Quality Natural Spices NET WT. 12 oz., UPC 818685010517; 3) Salma Natural Cumin NET WT. 12 oz., UPC 023913159085; 4.) Spice Class All Natural Cumin Powder NET WT. 7 oz, UPC 815978004239 and… Event 70217 | Spice N' More Corp. | Food | Class I | 1 |
| 5 Jan 2015 | OHIO CITY PASTA Four Cheese Net Weight 12oz. (340g) FOUR CHEESE RAVIOLI CONTAINS: MILK, EGGS, WHEAT KEEP FROZEN UPC 8 38735 00011 4 FOOD DESIGNS, INC. 3117 Detroit Ave., Cleveland, Ohio 44113 | Food Designs Inc | Food | Class I | 2 |
| 31 Dec 2014 | Reo Country Style Chili Seasoning NET WT 2 OZS (67G) Reo Spice & Seasoning, Inc. Huntsville, TX 77320 (936)294-0222; Reo Country Style Chili Seasoning NET WT 4 OZS(113G) Reo Spice & Seasoning, Inc. Huntsville, TX 77320 (936)294-0222; Reo Country Style Chili Seasoning NET WEIGHT ONE POUND Reo Spice & Seasoning, Inc.… | Reo Spice & Seasoning, Inc | Food | Class I | 9 |
| 27 Dec 2014 | Karm'l Dapple; Net Wt. 4 oz. (124g) Brown/Peanuts. Sold in Single size and 3 pack (12 oz. (340g) and Halloween Ingredients: Fresh Selected Apples, Sugar, Water Corn Syrup, Nonfat Dry Milk Solids, Cottonseed shortening and/or soybean oil, corn and soy cereal parts, flour, salt, lecithin, soda, Artifical Flavors and… | California Snack Foods Inc | Food | Class I | 4 |
| 26 Dec 2014 | Beechwood Smoked and Atlantic Salmon sliced sides, whole sides, and trimmings under the following brands; Coastal Harbor SKU: 8 30859 01183 0, Channel Island SKU: 8 30859 03093 0, Atlantic Smoked SKU: 8 30859 01253 0, Harbor Point SKU: 8 30859 01515 9, Local Abundance SKU: 8 30859 03075 5, Fresh & Easy 4oz. , Local… | The Santa Barbara Smokehouse, Inc. | Food | Class I | 12 |
| 24 Dec 2014 | Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425 | Advanced Sterilization Products | Device | Class II | 1 |
| 24 Dec 2014 | MYC Ingredients, Inc. Ground Cumin-ETO treated, NET WT 50 LBS. DISTRIBUTED BY: MYC Ingredients 718-793-3310 Event 70213 | Name withheld | Food | Class I | 1 |
| 24 Dec 2014 | Texamerican Chili Powder: 5 lbs. Item Number: ARCH064-50; 10 lbs. Item Number: TF5002 (R&D only). | Texamerican Food Blending, Inc. | Food | Class I | 8 |
| 23 Dec 2014 | Kona Coffee Frozen Pops 4.0 fl oz. frozen pop is individually packaged in a sealed plastic bag; 24 pops/case. Product is labeled in part, "***dark roast 100% kona coffee, cream, milk, skim milk powder, non-gmo cane sugar, less than 0.4% stabilizer (carob bean gum, guar gum, soy lecithin, carrageenan)***Seattle Pops… | Name withheld | Food | Class I | 6 |
| 22 Dec 2014 | SpermMar Test 0.7ml Beads Particles Label on bottle: SpermMar Test IgA 0.7ml Beads/Particles-50 Tests IND REF SPMA_S LOT Expiration DO NOT FREEZE/NE PAS CONGELER FertiPro N.V. Label on box: SpermMar Test IGA 50 Determination Test Kit CONTENTS 1 vial SpermMar Latex Particles 0.7 ml REF SPMA_S FertiPro FertiPro N.V.… Event 70131 | Vitrolife Inc | Device | Class II | 1 |
| 22 Dec 2014 | Granny Smith Apples, "Granny's Best" or "Big B"; sold in 40-45 lb. cases with cardboard trays or in 3 lb. poly bags (~12 apples). 5 lb. poly bags (~ 18 apples) and loose fill TriWall containers ~ 700 lbs. Bidart Bros., Bakersfield, CA 93312 | Name withheld | Food | Class I | 2 |
| 19 Dec 2014 | Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticating, shaping, and smoothing of bones and teeth in a wide variety of surgical procedures, including, but not limited to general orthopaedic… | Synthes, Inc. | Device | Class II | 1 |
| 19 Dec 2014 | B-Lipo, 30 Capsules, Manufactured by KM DALI, Kunming, China for Bethel Nutritional Consulting, Inc.599 West 190th Street, Suite #1 NYC, NY 10040. | Bethel Nutritional Consulting, Inc | Drug | Class II | 1 |
| 18 Dec 2014 | The package reads in part "***Northern Chef***GLUTEN FREE, OVEN READY LIGHTLY COATED COD***KEEP FROZEN/DO NOT REFREEZE***NET WT 10 OZ.(284g) UPC 8 7797100274 2 Product number 707300461 12/10oz bags placed in a Master Case weighing 7.5lbs Master Case UPC - GTN 14-10877971002749 Event 70061 | Tai Foong U.S.A., Inc | Food | Class II | 1 |
| 18 Dec 2014 | Guava filled pastry ("Pastelillo de Guayaba" in Spanish) 2.5 oz and 10 oz. | Vitony Bakery, Inc. | Food | Class II | 1 |
| 17 Dec 2014 | University of Alabama Birmingham TPN Neonatal Starter Bag, compound vol: 100 ml, Trophamine 4% Dextrose 10%, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box. each container is lined with a polystyrene insert; CAPS, Allentown, PA | Central Admixture Pharmacy Services, Inc. | Drug | Class I | 34 |
| 16 Dec 2014 | Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) staining. Product Usage: NCL-L-CD15 is intended for the qualitative identification by light microscopy of CD15 molecules in paraffin sections. The clinical interpretation of any staining or its absence should be… | Leica Microsystems, Inc. | Device | Class II | 1 |
| 12 Dec 2014 | Hydroxocobalamin Injection Solution 1 mg/mL Inj., Rx, compounded by American Specialty Pharmacy, Plano, TX 75075 214-919-2090. NDC 99999-9994-27 Event 70013 | American Specialty Pharmacy | Drug | Class II | 1 |
| 4 Dec 2014 | DBX Mix, 20 cc, Product Code: 058200. Demineralized Bone Matrix Mix, bone void filler. | Musculoskeletal Transplant Foundation, Inc. | Device | Class II | 1 |
| 4 Dec 2014 | 0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, Product Code 2B0043, NDC 0338-0553-18. | Baxter Healthcare Corp | Drug | Class I | 1 |
| 3 Dec 2014 | MitoXANTRONE Injection, USP, (concentrate) 2 mg/mL, Rx Only. Hospira, Lake Forest, IL 60045, Product of Australia. Available in a) 20 mg/10 mL Multi Dose Vial (NDC: 61703-343-18); b) 25 mg/12.5 mL Multi Dose Vial (NDC: 61703-343-65); c) 30 mg/15 mL Multi Dose Vial (NDC: 61703-343-66). | Hospira Inc. | Drug | Class I | 1 |
| 2 Dec 2014 | PureLife Naturals Adult Multi-Plus Multi-Vitamins & Minerals Plus Herbs, 60 Pure Caps HDPE bottle | ReNew Life Formulas, Inc. | Food | Class II | 2 |
| 26 Nov 2014 | Mini Naan Eight (8) nann packaged in coated paper printed board and transparent wrap with a net weight of 12.6 oz (360 g) per package and old under the US Foods brand. Product is labeled with instructions to keep frozen until use. Eight (8) packages per case. Event 69998 | fgf brands, inc | Food | Class II | 1 |
| 24 Nov 2014 | Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 The Autoject E1 is an injector used by patients to inject drugs as prescribed by their doctor. | Owen Mumford USA, Inc. | Device | Class II | 1 |
| 20 Nov 2014 | Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upgraded to CDAS, Part Number: 9065 and 9067. These rechargeable batteries are used to supply power to the following products: Wireless ECG Module used with the Precess MRI compatible Patient Monitoring System, Wireless SpO2 Module used with… | Philips Medical Systems, Inc. | Device | Class II | 1 |
| 19 Nov 2014 | RICOS Tostaditos Chiviricos Fried Dough Crispy and Delicious Net Wt. 2-1/4 oz. (64g) | Ricos Tostaditos, Inc. | Food | Class II | 3 |
| 17 Nov 2014 | Nutri-Dyn, 5-HTP Extra Strength, Pharmaceutical Grade from Switzerland, Dietary Supplement 60 capsules in plastic bottle, 5-Hydroxytryptophan (5-HTP) 200 mg., Other Ingredients: Rice flour, magnesium stearate, and silica, UPC # 6 96859 02947 9, Sku # R200E. Event 69933 | Nutri-Dyn Midwest, Inc. | Food | Class III | 1 |
| 14 Nov 2014 | 5-Aminolevulinic Acid Hydrochloride active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada | Attix Pharmaceuticals | Drug | Class II | 470 |
| 10 Nov 2014 | Mucinex DM (guaifenesin 600mg and dextromethorphan HBr 30mg), extended-release bi-layer tablets, 2 tablets per pouch (NDC 63824-056-72), OTC, Distributed by Reckitt Benckiser, Parsippany, NJ 07054-0224 Made in England | Reckitt Benckiser LLC | Drug | Class III | 1 |
| 7 Nov 2014 | 3i T3 Non-Platform Switched Tapered Implant Rx Only; 3.25 x 8.5 - 15.0 mm Dental Implants. | Biomet 3i, LLC | Device | Class II | 3 |
| 30 Oct 2014 | ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to transfer data for diabetes management. | Roche Diabetes Care, Inc. | Device | Class II | 1 |
| 23 Oct 2014 | ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH. | TEM Systems Inc | Device | Class II | 1 |
| 1 Sep 2014 | Fluid Management System P4000; for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic procedures. Event 69996 | Thermedx LLC | Device | Class II | 1 |
| 24 Jun 2014 | Bard Peripherally Inserted Central Catheter (PICC) and Dialysis catheter kits containing Safe-Cut Safety Scalpels. | Bard Access Systems | Device | Class II | 1 |
| 18 Apr 2014 | French Broad Chocolates, Bubbie's Almond Bar, 60g (2.1 oz) bar, with aluminum foil with polyester ribbon & paper outer wrapper Event 70366 | Name withheld | Food | Class III | 1 |
| 2 Oct 2013 | Potassium Chloride, microencapsulated extended-release tablets, 20 mEq, blister card of 30/10 cards in a corrugated shipper, Rx only, Manufactured by Upsher-Smith Laboratories, Inc. Minneapolis, MN 55447 for Sandoz, Inc., Princeton, NJ 08540 Repackaged by Cardinal Health Zanesville, OH 43701 | Cardinal Health | Drug | Class III | 1 |
| 1 May 2013 | CooperSurgical TransWarmer Infant Transport Mattress with WarmGel P/N 20421 Private label: NovaPlus TransWarmer Infant Heat Therapy Mattress with WarmGel. P/N V6390 Provides warmth during transport of infant within the hospital or between hospitals | CooperSurgical, Inc. | Device | Class II | 1 |
| 27 Feb 2013 | The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer analgesia safely and effectively within clinician programmed limits. | Hospira Inc. | Device | Class II | 2 |