| 3 Jun 2016 | NatureBox Country Ranch Sunflower kernels; 5 oz. (142g) customer stand up pouch. UPC: 8 52523 00535 8 Ingredients: Sunflower kernels, Sunflower Oil, Buttermilk Powder, Salt, Rice Syrup Solids, Onion and Garlic, Sour Cream Powder (cultured milk, nonfat milk), Tomato Powder, Cheese Powder (cheddar cheese, cultures… | NatureBox, Inc. | Food | Class I | 3 |
| 1 Jun 2016 | CHLORHEXIDINE GLUCO. 0.12% ORAL RINSE, Packaged in 473 ML Bottles, Rx Only. MFG: HI-TECH PHARMACAL CO., INC., AMITYVILLE, NY 11701, Packaged By: Aidarex PHARMACEUTICALS. NDC: 33261-0447-01. | Aidarex Pharmaceuticals LLC | Drug | Class II | 1 |
| 1 Jun 2016 | CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01 | Aidarex Pharmaceuticals LLC | Drug | Class III | 1 |
| 30 May 2016 | Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg, Rx only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, China; Distributed by: Solco Healthcare U.S., LLC, Cranbury, NJ 08512, NDC 43547-331-09. | Prinston Pharmaceutical Inc | Drug | Class III | 1 |
| 28 May 2016 | Pramipexole Dihydrochloride Extended Release Tablets, 0.375 mg, Rx Only, 30 count bottles, Manufactured By: Par Pharmaceutical Companies, Inc., Chestnut Ridge, NY 10977, NDC 10370-251-11 Event 74270 | Par Pharmaceutical | Drug | Class III | 1 |
| 27 May 2016 | Big Sur Breakfast Burrito; A delicious blend of roasted potatoes & red peppers, smoked seitan and seasoned tofu. Net Wt. 7.0 oz. (198 g). Ingredients: Filling: Russet Potatoes, tofu (water, soybeans, Calcium sulfate, Calcium chloride, Sweet Earth Traditional Seitan (water, wheat gluten, soy sauce (water soybeans,… Event 74281 | Sweet Earth Inc. | Food | Class I | 1 |
| 25 May 2016 | Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0185-0630-01 | Sandoz Inc | Drug | Class III | 1 |
| 24 May 2016 | Crit Line in a Clip (CLiC). CliC P/N: CL 10041001 CLiC is a continuous real-time monitor for non-invasive hematocrit oxygen saturation and percent change in blood volume measurement during hemodialysis treatment. Used in conjunction with the Fresenius 2008T Hemodialysis Machines as follows: Model: 190895 2008T GEN 2… | Fresenius Medical Care Renal Therapies Group, LLC | Device | Class II | 1 |
| 23 May 2016 | EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide, Rx Only, PRB35-08-040-080. The Protege EverFiex" Self-expanding Peripheral Stent System is a self-expanding Nitinol stent system intended for permanent implantation. The self-expanding stent is made of a nickel titanium alloy… | Ev3, Inc. | Device | Class II | 1 |
| 23 May 2016 | Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsules, 60-count bottles, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC 0 00950 86006 8. | Valeant Pharmaceuticals North America LLC | Drug | Class III | 1 |
| 23 May 2016 | Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY TRACT ANTIBACTERIAL, Rx Only , 240 mL bottle, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Mfg. by: Sun Pharmaceutical Industries, Inc., Bryan, Ohio 43506, NDC 57664-239-32 | Nostrum Laboratories, Inc. | Drug | Class II | 1 |
| 23 May 2016 | Honest Kids-Super Fruit Punch, Organic Juice Drink, 59 fluid oz. bottle, 006 57622 41273 7, Honest Tea, Inc., 4827 Bethesda Ave., Bethesda, MD 20814. | Coca-Cola Company (The) | Food | Class II | 1 |
| 21 May 2016 | (Albertsons/Safeway/Basha Hometown Grocers) Oriental Salad with Sesame Ginger Dressing, Net Wt.10 oz.(284g), 24 pieces per case, UPC 78279602691; (Food 4 Less) Oriental Salad with Sesame Ginger Dressing, Net Wt. 13 oz. (369 g), UPC 78277602840 Event 74216 | Papa John's Salads and Produce, Inc. | Food | Class I | 1 |
| 20 May 2016 | Sharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USP, Product No. J2558N Event 74230 | SSC- Surgical Specialties Corporation | Device | Class II | 1 |
| 19 May 2016 | 6534-08N InterActive Implant Open-Tray Transfer Narrow Part Number: 6534-08N Product Usage: Intended Use of Implant Direct Open Tray Transfers are to capture implant position in an elastomeric impression of the mandible or maxilla. Open Tray transfers stay within the Impression material prior to delivery to the… | Implant Direct Sybron Manufacturing, LLC | Device | Class II | 1 |
| 19 May 2016 | Doxycycline, USP Capsules 40 mg, Packaged in 30 ct Bottles, Rx Only. Marketed by: Prasco Laboratories, Mason, OH 45040 USA, Manufactured by: Catalent Pharma Solutions, LLC, Winchester, Kentucky 40391. NDC: 66993-815-30. Event 74209 | Galderma Laboratories, L.P. | Drug | Class III | 1 |
| 18 May 2016 | Monaco RTP System Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. | Elekta, Inc. | Device | Class II | 1 |
| 18 May 2016 | Mycophenolate Mofetil, Bulk Powder, Quantity 1000 g, For prescription compounding use and medical manufacturing or processing only, Attix Pharmaceuticals, Toronto, Canada Event 74361 | Attix Pharmaceuticals Inc | Drug | Class III | 1 |
| 18 May 2016 | white and dark chocolate cashew turtles and tortoises | The Caramel Factory, LLC. | Food | Class I | 26 |
| 17 May 2016 | Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder (AS) System 2.0. The Dome Centric connects the Humeral Stem to the Humeral Head and allows setting an inclination and retroversion positioning. The Anatomical Shoulder System is intended for long-term implantation into the human shoulder… | Zimmer Gmbh | Device | Class II | 1 |
| 17 May 2016 | AVEA Comprehensive ventilator, 17310-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. | Carefusion 211 Inc dba Carefusion | Device | Class I | 12 |
| 17 May 2016 | Access 2 Immunoassay System, Remanufactured, Catalog No. 386220 is an invitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids. | Beckman Coulter Inc. | Device | Class II | 1 |
| 17 May 2016 | Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL bottles, Mfd. by: Akorn, Inc., Lake Forest, IL 60045 --- NDC 17478-221-12 | Akorn, Inc. | Drug | Class II | 1 |
| 17 May 2016 | 17-0H PROGESTERONE 250MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Well Care Compounding Pharmacy | Drug | Class II | 51 |
| 16 May 2016 | Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Metered Dose Inhalers(pMDIs). Event 74197 | FSC Laboratories, Inc | Device | Class II | 1 |
| 16 May 2016 | Potassium CHLORide added to 5% Dextrose Injection, 20 mEq 250 mL Bag, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141, NDC 61553-836-11, Service Code 2K5836. | Pharmedium Services, LLC | Drug | Class II | 1 |
| 16 May 2016 | VP-CH-PNV Prenatal/Postnatal capsules, prenatal supplement, 30-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals, LLC, Tampa, FL 33619, NDC 69543-224-30 | Virtus Pharmaceuticals, Llc | Drug | Class III | 1 |
| 13 May 2016 | MEGA 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK MEGA 7.5Fr. 40cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK MEGA 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK MEGA 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit, STATLOCK & APA | Datascope Corporation | Device | Class II | 1 |
| 13 May 2016 | Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg, packaged in 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC. Nashville, TN 37217. NDC 76439-0309-10 | Virtus Pharmaceuticals, Llc | Drug | Class III | 1 |
| 12 May 2016 | COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage. | Baxter Healthcare Corp | Device | Class II | 3 |
| 12 May 2016 | iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment. | Elekta, Inc. | Device | Class II | 1 |
| 12 May 2016 | The Farmer’s Market, Chopped Asian, Chopped Lettuce Blend, Roasted Chicken, Cherry Infused Cranberries & Almond Crunch, Square Noodles and Sesame Ginger Dressing, Net Wt. 6.25 oz. (177g), packed in clear rigid plastic containers, Fresh Express Incorporated, P.O. Box 80599, Salinas, CA 93912. | Fresh Express Incorporated | Food | Class I | 1 |
| 11 May 2016 | Persona Trabecular Metal„ Tibia; Persona„ Trabecular Metal„ Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants. | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 11 May 2016 | Norian Drillable Inject 3 CC-Sterile; catalog # 07.704.003S Intended for bony voids or defects of the extremities and pelvis that are not intrinsic to the stability of the bony structure. | Synthes (USA) Products LLC | Device | Class II | 3 |
| 11 May 2016 | tabcin ACTIVE M.R. Capsules, 12-count box , UPC 7501008485057 | Profarma Distributors LLC | Drug | Class II | 5 |
| 10 May 2016 | SIOOA I (EP I84) Rabbit Monoclonal Antibody; Catalogue numbers 408R-14, 408R-15, and 408R-16; Part number: 470361. Intended for identifying by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin embedded tissue sections using IHC test methods. | Cell Marque Corporation | Device | Class II | 1 |
| 10 May 2016 | Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Guide Wire for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. Event 74229 | CarboFix Orthopedics, Ltd. | Device | Class II | 1 |
| 10 May 2016 | Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4.4.001, Fujifilm Synapse PACS software version 4.4.004, Fujifilm Synapse PACS software version 4.4.010 and Fujifilm Synapse PACS software version 4.4.020 FUJIFILM Synapse Workstation Software (a Picture Archiving And… | Fujifilm Medical Systems U.S.A., Inc. | Device | Class II | 1 |
| 10 May 2016 | TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Screws The FS2030 Depth Gauge is used by the physician to determine the correct screw length when implanting a 2.0 or 2.5mm TS Series screw for the Ti6 Internal Fixation System. | Integra LifeSciences Corp. | Device | Class II | 1 |
| 10 May 2016 | Coppertone SUNSCREEN LOTION, CLEARLY SHEER, BROAD SPECTRUM SPF 50, 5 FL OZ (147mL), OTC, Dist by: Bayer HealthCare LLC, Whippany, NJ 07981 --- NDC 11523-7391-1, UPC 00041100005762 Event 74138 | Bayer Health Care LLC | Drug | Class II | 1 |
| 10 May 2016 | Publix Cranberry Nut & Seed Mix, 7.05 ounce plastic container. Manufactured by Publix Supermarkets in Lakeland, FL. | Publix Super Markets, Inc. | Food | Class I | 1 |
| 10 May 2016 | Karlsburger, Mesquite Seasoning Mix & Marinade, Item 46402, Net WT 2 lbs in plastic shaker jars. | Karlsburger Foods, Inc. | Food | Class II | 1 |
| 10 May 2016 | 16 oz. foil packages of Frontier Co-op Hojicha Tea Certified Organic Camellia sinensus, Norway, IA 52318 | Frontier Natural Products CO-OP | Food | Class II | 1 |
| 9 May 2016 | Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and positive controls are used to detect antibodies in patient serum by the complement fixation (CF) procedure to aid in the diagnosis of four specific fungal diseases: Histoplasmosis, blastomycosis, coccidioidomycosis, and… | Immuno-Mycologics, Inc | Device | Class II | 1 |
| 9 May 2016 | MSK 1.5T Extreme MR Scanner, a diagnostic imaging device | GE Healthcare, LLC | Device | Class II | 2 |
| 9 May 2016 | GE Revolution CT The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. | GE Healthcare, LLC | Device | Class II | 1 |
| 9 May 2016 | SEAL,IS4000 PORTS,5MM-8MM,BOX of 10; Model numbers: 470361-03, 470361-04, 470361-05, 470361-06; Part number: 470361. The da Vinci Xi Surgical System cannula sterile single use disposable cap for each cannula . When attached to the cannula, the seal maintains insufflation when the cannula is empty and when the… | Intuitive Surgical, Inc. | Device | Class II | 2 |
| 9 May 2016 | Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surgery the HLM Tubing Sets with Bioline… | Datascope Corporation | Device | Class II | 1 |
| 9 May 2016 | 24 oz RM German Choc. Dessert Bar Cake. Net Wt: 24 oz, K Dairy, UPC 752716883308, Vollmer's Bakery - 4004 Grape Street - Denver, CO - 303-388-8393. Packaging: Plastic Container, 8 per case, Keep frozen, refrigerate after opening. Event 74161 | Frozen Inc. | Food | Class II | 1 |
| 9 May 2016 | Let's Talk Health Energizer Drink Mix Citrus 0.3oz UPC #91131180631 | Let's Talk Health, Inc. | Food | Class I | 6 |
| 6 May 2016 | Ariol is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and counting of cells of interest based on particular color, intensity, size, pattern, and shape. This particular Ariol software application is… | Leica Biosystems Richmond Inc. | Device | Class III | 1 |
| 6 May 2016 | Vancomycin Hydrochloride for Injection, USP, 10 g, 100 mL vial, Rx only, Hospira, Lake Forest, IL, NDC 0409-6510-01 | Hospira Inc. | Drug | Class II | 1 |
| 6 May 2016 | labled in part "Uncle Buck's Sweet & Salty trail mix" packaged in a clear 3 oz plastic bag with attached green and orange label with yellow and black writing. item number: 7339, UPC # 752545073390. | Rucker's Wholesale & Service Co., Inc. | Food | Class I | 1 |
| 5 May 2016 | Sterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tube, Ref: V5-10314, ID: 7.0 mm, Rx Only, Manufactured by: Teleflex Incorporated. A tracheal tube is inserted into a patients mouth or nose for airway management. | Teleflex Medical | Device | Class II | 1 |
| 5 May 2016 | Ellipse ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Products. | Ellipse A/S | Device | Class II | 2 |
| 5 May 2016 | Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and… | Medical Components, Inc dba MedComp | Device | Class II | 1 |
| 5 May 2016 | Stryker PowerPRO (XT, IT, or TL) Cots Stretcher, Wheeled The Stryker Power-PRO" are powered ambulance cots are designed to support and transport a maximum weight of 700 lb. (318 kg) in pre-hospital and hospital environments. | Stryker Medical Division of Stryker Corporation | Device | Class II | 1 |
| 5 May 2016 | Bobo's Oat Bars, Gluten Free, Lemon Poppyseed, Net Weight 3 oz (85g), packaged in clear plastic, 12 bars per sleeve, also sold as individual units. Manufactured by Simply Delicious, Inc. | Simply Delicious Inc. | Food | Class II | 1 |
| 5 May 2016 | Dakota Style Roasted & Salted Sunflower Kernels, Net Wt. 3.5 oz. plastic bag. UPC 84872-20172 | Dakota Style, Inc | Food | Class I | 2 |
| 5 May 2016 | Korean Noodles in a Savory Black Bean Sauce, 46.6oz, UPC 7-53214-73298-3, Food Item No. 1027557, Pack Size: 8. | Pulmuone Foods Usa | Food | Class I | 3 |
| 5 May 2016 | NUTS Sunflower Seeds Roasted & Salted Vending Nut Co. Fort Worth, Texas 76107 Net Wt. 16 oz. (1 LB.) 454g packaged in plastic bags | Vending Nut Co Inc | Food | Class I | 2 |
| 5 May 2016 | Publix Deli, Wheatberry Salad, sold in 3.5 oz clamshell, 1 lb Grab and Go kit, and Chef Select custom order behind the deli counter. Received at retail store as a 12.75 lbs kit. Ingredients are combined at retail store. Manufactured for Publix Supermarkets in Lakeland, FL | Publix Super Markets, Inc. | Food | Class I | 1 |
| 4 May 2016 | ExacTrac Vero is a Patient Positioning System for Radiation therapy. | Brainlab AG | Device | Class II | 1 |
| 4 May 2016 | Stryker FlowPort II Adapter: Model number: 00CAT00778 The FlowPort II Adapter is intended to connect the FlowPort II Cannulas to commercially available, 4mm arthroscopes in surgical procedures. | Stryker Corporation | Device | Class II | 1 |
| 4 May 2016 | Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid) | Cordis Corporation | Device | Class II | 2 |
| 4 May 2016 | OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-01. | Fresenius Kabi USA, LLC | Drug | Class II | 2 |
| 4 May 2016 | Golden Gourmet Snacks Veggie Chips; Net Wt. 12 OZ; Bickel's Snack Foods, Inc., York, PA 17404 Lot codes: 26SEP16 Z4D1 and 26SEP16 Z5D1 | Bickel's Snack Foods Inc | Food | Class I | 1 |
| 4 May 2016 | Mountain Thins “Trail Mix” flavor, packaged in a stand-up film pouch (resealable), net wt. 5.3 oz. The UPC is 0 41770 33370 7 Event 74033 | Brown & Haley Inc. | Food | Class I | 1 |
| 3 May 2016 | Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Model 97714, Implantable Neurostimulators. Used to treat chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain. Event 74059 | Name withheld | Device | Class II | 1 |
| 3 May 2016 | Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set. | Materialise USA LLC | Device | Class II | 1 |
| 3 May 2016 | BLUE BELL ICE CREAM Rocky Road pint | Blue Bell Creameries, L.P. | Food | Class II | 1 |
| 3 May 2016 | Aldi's Millville protein chew bars, peanut, dark chocolate & almond packaged 5 bars per box in a yellow and brown box with brown and white lettering. | Schulze & Burch Biscuit Co | Food | Class I | 2 |
| 3 May 2016 | Kroger CRANBERRY DELIGHT TRAIL MIX NET WT 14 OZ INGREDIENTS: DRIED CRANBERRIES ***ALMONDS, SUNFLOWER SEEDS*** UPC 0 11110 89869 2 DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202 | The Kroger Co | Food | Class I | 3 |
| 2 May 2016 | Siemens Healthcare ADVIA Centaur Tnl-Ultra Assay . In-Vitro Diagnostic for quantitative determination of cardiac troponin For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, heparinized plasma, or EDTA plasma using the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur… | Siemens Healthcare Diagnostics, Inc | Device | Class II | 1 |
| 2 May 2016 | CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified… | Leica Biosystems Richmond Inc. | Device | Class III | 1 |
| 2 May 2016 | 1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 24 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations. | Synthes (USA) Products LLC | Device | Class II | 3 |
| 2 May 2016 | DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument. Part number 351.43 | Synthes (USA) Products LLC | Device | Class II | 1 |
| 2 May 2016 | LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile; Indicated for fractures, osteotomies, and non-unions of the radius and other small bones. | Synthes (USA) Products LLC | Device | Class II | 1 |
| 2 May 2016 | STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses. Event 74067 | Staar Surgical Co. | Device | Class II | 1 |
| 2 May 2016 | Dicloxacillin Sodium Capsules, USP 250mg, Rx Only, 100 Capsule Bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc., Princeton, NJ 08540, Product of Spain, NDC 0781-2248-01 | Sandoz, Inc | Drug | Class III | 2 |
| 2 May 2016 | Werner Brand Butter Toffee Peanuts, net wt. 2.25 oz, UPC 7 09972 80113 3 Werner Brand Butter Toffee Peanuts, net wt. 6 oz., UPC 7 09972 80027 3 The ingredients statement declared: Peanuts, Sugar, Butter, Salt. The label contains an advisory statement Allergen Information: "***This product is manufactured and packaged… | Werner Gourmet Meat Snacks, Inc. | Food | Class II | 2 |
| 30 Apr 2016 | Fresh Harvest Ice NET WT 8 LB and Fresh Harvest Ice NET WT 16 LB packaged in clear plastic bags Event 74022 | Brookshire Brothers LTD-Central Bakery Plant | Food | Class II | 1 |
| 29 Apr 2016 | Code 2013 Spicy Mac & Cheese Bites Breaded Macaroni & Monterey Jack Cheese O 'Steen Meat Specialties Inc. 2126 N. Broadway Oklahoma City, OK 73103 Phone (405) 236-1952 KEEP FROZEN Net Weight 10 LBS. UPC: 7-49616-02013-1 Event 74000 | O'Steen Meat Specialties, Inc. | Food | Class II | 1 |
| 28 Apr 2016 | CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and identified Custom Paks | Alcon Research, Ltd. | Device | Class II | 1 |
| 28 Apr 2016 | Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #: 401450, 401877. Indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures. | Stryker Sustainability Solutions | Device | Class II | 1 |
| 28 Apr 2016 | Maestro Air Motor Pneumatic cranial drill motor. The Maestro Air Pneumatic System is a pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories. | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 1 |
| 28 Apr 2016 | Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10 mL syringe). For flushing of IV catheters and IV tubing only. Event 74045 | Excelsior Medical Corp | Device | Class II | 1 |
| 28 Apr 2016 | Zoloft (sertraline HCl) tablets, 100 mg*, 30 count bottles, Rx only, Distributed by Roerig, Division of Pfizer, Inc., NY NY 10017, NDC 0049-4910-30. | Pfizer Inc. | Drug | Class II | 1 |
| 28 Apr 2016 | Sclerosol Intrapleural Aerosol (sterile talc powder), Intrapleural administration, 4 g Canister, Rx Only, Distributed by: Bryan Corporation, Woburn, MA 01801, USA, NDC 63256-100-30 Event 73896 | Lymol Medical | Drug | Class II | 1 |
| 28 Apr 2016 | Walnut Delights 6 Pack Net Weight: 9 oz. PLU #69690 UPC: 2 69690 20399 7 Giant Eagle, LLC, Pittsburgh, PA | Giant Eagle, Inc. | Food | Class I | 3 |
| 28 Apr 2016 | Fresh Long Chili Peppers, Raw, 10 lb box. Imported from Dominican Republic. Event 73996 | Patel Shippers Inc | Food | Class I | 1 |
| 27 Apr 2016 | Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a spinal fixation construct. Rx Only Provided non Sterile. | Orthofix, Inc | Device | Class II | 1 |
| 27 Apr 2016 | Norditropin FlexPro Somatropin (rDNA origin) injection, 30 mg/3 mL Prefilled Pen, Rx only, Novo Nordisk Inc., Plainsboro, NJ --- NDC 0169-7703-21 | Novo Nordisk Inc | Drug | Class II | 1 |
| 27 Apr 2016 | Hectorol (doxercalciferol injection) 2 mcg/1mL, Rx only, Manufactured by: Genzyme Biosurgery Corporation 500 Kendall Street, Cambridge, MA 02142, NDC 58468-0126-1 Event 74046 | Genzyme Corporation / Genzyme Biosurgery | Drug | Class III | 1 |
| 27 Apr 2016 | Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-31), packaged in 10 x 300 mL Single Use Container bags per Box Pack (NDC 0703-9060-33), Rx only, Manufactured In Hungary By: Teva Pharmaceutical Works Ltd., Hungary, H-2100 Godollo, Tancsics M. ut 82 Hungary; Manufactured For: Teva… | Teva North America | Drug | Class II | 1 |
| 27 Apr 2016 | Corn Seasoning Salt Blue Cheese and Herb. Plastic bottles, 6 bottles per case. various sizes: Wt. 5.7 oz. The UPC is 8 14417 02089 2. Product is labeled in parts: "***CORN SEASONING SALT BLUE CHEESE & HERB***INGREDIENTS: BLUE CHEESE, JACOBSEN SEA SALT, OREGANO, THYME***Manufactured by Jacobsen Salt Co. Portland, OR… Event 74003 | Jacobsen Salt Co. | Food | Class II | 1 |
| 27 Apr 2016 | Mighty Leaf Tea Company Organic Ginger Peach Iced Tea; 100/1 oz. per case Item number 60001. UPC: 00656252600019 Event 74021 | Name withheld | Food | Class II | 1 |
| 27 Apr 2016 | Choice Products Supreme Elixir 32oz. | World's Choice Products | Food | Class I | 3 |
| 26 Apr 2016 | Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive and open surgical procedures to facilitate cutting, preparation, mobilization, and coagulation of tissue. Model #'s MIC3112, MIC3122, MIC3132, MIC3142, MIC3152, MIC3162. | STERILMED, INC. | Device | Class II | 1 |
| 26 Apr 2016 | WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery through intravascular ports, 20 units per case, Catalog Number 471734. Usage: Infusion of solution/medication into implanted intravascular ports. | B. Braun Medical, Inc. | Device | Class II | 1 |
| 26 Apr 2016 | Torque Limiting Handle: PRECIMED, T-Handle Torque, Non Sterile. Handle: Customer Number/Model: MCL120014 T14000, TLT911-50-S20 TLT911-50-S20, TLT911-15-S01 TLT911-15-S01, TLTS0007-20-S19 TLTS0007-20-S19, TLT911-35-S01 TLT911-35-S01. | Greatbatch Medical | Device | Class II | 3 |
| 26 Apr 2016 | 4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297 VACUETTE Glycolytic Inhibitor Tubes contain an antiglycolytic agent, sodium fluoride, and an anticoagulant, potassium oxalate. The product is suitable for the analysis of blood glucose and lactate | Greiner Bio-One North America, Inc. | Device | Class II | 1 |
| 26 Apr 2016 | 8 " Single Layer Red Velvet Cake Event 73957 | CSM Bakery Products | Food | Class II | 1 |
| 26 Apr 2016 | White Cupcakes with Pink Icing, UPC #10074865110140 | Name withheld | Food | Class II | 4 |
| 25 Apr 2016 | Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits. Cardiology: The Volcano Universal (Core /Core Mobile), S5iz Platform Imaging System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral… | Volcano Corporation | Device | Class II | 1 |
| 25 Apr 2016 | BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. | Siemens Medical Solutions USA Inc. | Device | Class II | 4 |
| 25 Apr 2016 | Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Dose Vial, Rx only, Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-472-37 | Fresenius Kabi USA, LLC | Drug | Class II | 1 |
| 25 Apr 2016 | Ivory Teff Flour, bulk 25 lb bags. This product is a raw agricultural commodity and it is not a ready to eat product. It must go through further processing, including heat, before eating. Product is labeled in parts "***IVORY TEFF FLOUR***Origin: South Africa***distributed by Bridgewell Food Products***Clackamas,… Event 73982 | Bridgewell Resources LLC | Food | Class I | 1 |
| 22 Apr 2016 | Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument. | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | Device | Class II | 1 |
| 22 Apr 2016 | Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012. Event 73949 | Accriva Diagnostics Inc., dba ITC, dba Accumetrics | Device | Class II | 1 |
| 22 Apr 2016 | Biograph mCT-X 4R, MATERIAL NUMBER 10248670 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. | Siemens Medical Solutions USA Inc. | Device | Class II | 33 |
| 22 Apr 2016 | Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue Part Number: 54343, 54344, and 100105-01. | Natus Medical Incorporated | Device | Class II | 1 |
| 22 Apr 2016 | CADD Administration Sets with Flow Stop, Product Reorder No: 21-7321-01, 21-7321-24, 21-7322-01, 21-7322-24, 21-7323-24, 21-7324-01, 21-7324-24, 21-7333-24, 21-7336-01, 21-7336-24, 21-7339-01, 21-7339-24, 21-7359-01, 21-7359-24, 21-7383-01, 21-7383-24, 21-7390-01, 21-7390-24, 21-7391-01, 21-7391-24, 21-7394-01,… | Smiths Medical ASD, Inc. | Device | Class II | 1 |
| 22 Apr 2016 | BioSync Anatomic Cotton Wedge, 16 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot. | Arthrex, Inc. | Device | Class II | 6 |
| 22 Apr 2016 | archer farms Greek-Inspired Spinach & Feta Cheese ARTISAN PIZZA, NET WT 14.9 OZ (425g). UPC Code: 0-85239-30714-4. Pizza is frozen. Event 73956 | Sinco | Food | Class II | 1 |
| 22 Apr 2016 | 7-Eleven Fresh To Go Peanut Butter Cookie Net Wt 4.0 oz (114g). Manufactured by Bakery Express in Orlando, FL. | Bakery Express of Central Florida, Inc. | Food | Class II | 2 |
| 22 Apr 2016 | 7-ELEVEN FRESH TO GO SUGAR COOKIE WITH M&M CHOCOLATE CANDY, 2 pieces, NET WT. 4 OZ. The affected cookies are packed in a clear, plastic film, two cookies per package. Event 74024 | Dough Masters Co Inc | Food | Class II | 1 |
| 21 Apr 2016 | Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter Desflurane Agent and Bottles. Catalog # M35500 (D-Vapor) and M36700 (D-Vapor 3000). Anesthesia Vaporizer | Draeger Medical, Inc. | Device | Class II | 1 |
| 21 Apr 2016 | The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile. Intended for use in aspirating subcutaneous fatty tissue in patients desiring aesthetic body contouring and autologous fat collection. Event 74156 | Miami Fat Supply, Inc | Device | Class II | 1 |
| 21 Apr 2016 | Wicker's Black Label Steak Marinade, 16 Fl. Oz. (473.28 mL), Ingredients: Soy Sauce (Water, Salt, Hydrolyzed Soy Protein, Corn Syrup, Caramel Coloring), Vinegar, Herbs and Spices Event 74037 | Wicker's Food Products Inc | Food | Class II | 1 |
| 20 Apr 2016 | Angel Wings Complete Daily Multi with 146 nutrients including Anti-aging and Superfruit Antioxidants and 75 Plant Derived Minerals 120 Capsules UPC: 0-16158-01225-3 Liquid Assets, Inc. Tulsa, OK 74116 1-888-497-4535 www.ExceptionalProducts.org; Magzuma Zuma Supreme Daily Wellness 147 Whole Food Nutrients Anti-aging… | Liquid Assets Inc | Food | Class I | 2 |
| 20 Apr 2016 | Gourmet White Chocolate Macadamia Cookies, UPC 0007203695132, 4 Ct (Pack 24/4 Ct) | Name withheld | Food | Class II | 5 |
| 19 Apr 2016 | Surgical Table Cushion (HybriGel Pads) HybrGel Pads are an optional accessory to the Operon Surgical Table. The pads may be attached to the base section with a Velcro fastener. The HybriGel pad shapes and variants can differ depending on the scope of the delivery. | Berchtold Corp. | Device | Class II | 1 |
| 19 Apr 2016 | Nuvi Global StemVitae Multivitamin 30oz. Event 73937 | Nuvi Global Corporation | Food | Class I | 1 |
| 19 Apr 2016 | TranSmart, Ginger Cookie, 300-1.2oz Cookies, Net Weight 22.5 lbs/10.22 kg (Frozen). | CSM Bakery Products NA | Food | Class II | 42 |
| 18 Apr 2016 | 3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product Usage: Usage: The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral Nailing, Multiloc Humeral Nailing… | Synthes (USA) Products LLC | Device | Class II | 2 |
| 18 Apr 2016 | 0.9% Sodium Chloride a) 500 mL b) 2000 mL and c) 3000 mL bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Baptist Health Medical Towers Pharmacy and Infusion Services | Drug | Class II | 38 |
| 18 Apr 2016 | Pronutri Re-VITA-lize Tropical Orange Dietary Supplement 32 oz. Event 73924 | Pronutri, LLC | Food | Class I | 1 |
| 15 Apr 2016 | GE Healthcare, Discovery IGS 730. Indicated for use in generating fluoroscopic and rotational images of human anatomy. | GE Medical Systems, LLC | Device | Class II | 2 |
| 15 Apr 2016 | POROUS PATELLA 32MM X 10MM - 00587806532 POROUS PATELLA 35MM X 10MM- 00587806535 POROUS PATELLA 38MM X 10MM - 00587806538 POROUS PATELLA 41MM X 10MM - 00587806541 | Zimmer Trabecular Metal Technology, Inc. | Device | Class II | 6 |
| 15 Apr 2016 | HAWAIIAN DELIGHT ING: IMITATION SOUR DRESSING, PEACHES, PINEAPPLE, MANDERIN ORANGES, SUGAR CHERRIES KEEP REFRIGERATED NET WT. 4.5 LB. & 9 LB. (4.06KG) (2.03KG) F.L. HARTER & SONS INC. CINCINNATI, OHIO 45211 | Frank L Harter & Sons Inc | Food | Class I | 3 |
| 14 Apr 2016 | CytoScan Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray kit, and analysis software. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray kit, and analysis software: MOD R LA, CytoScan Dx Pre-PCR (-20°C) MOD T E W, CytoScan Dx… Event 73979 | Affymetrix Inc | Device | Class III | 1 |
| 14 Apr 2016 | Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite Valve Product Usage: Used for aspiration of medication from inverted bags or semi-rigid containers. Interavenous delivery of transferred medication(Device is not intended for direct infusion) | B. Braun Medical, Inc. | Device | Class II | 2 |
| 13 Apr 2016 | Lipase, Catalog No. OSR6x30 Product Usage: Lipase OSR6x30 is intended as a System reagent for the quantitative determination of Lipase activity in human serum on Beckman Coulter AU analyzers. | Beckman Coulter Inc. | Device | Class II | 5 |
| 12 Apr 2016 | Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 54mm, O.D. (Acetabular Cup), Catalog Number 140-01-54; For use in primary total hip arthroplasty. | Exactech, Inc. | Device | Class II | 6 |
| 11 Apr 2016 | PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression. | Biomet, Inc. | Device | Class II | 1 |
| 11 Apr 2016 | Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066. Top Assembly Part Numbers: 001103, 001314, 002110, 040906, 040904, 040756, 040758, 040658, 040680. Product Usage: Used to provide treatment for neonatal hyperbilirubinemia | Natus Medical Incorporated | Device | Class II | 1 |
| 11 Apr 2016 | EVARREST Fibrin Sealant Patch, Manufactured by: Omrix Biopharmaceuticals, Ltd, Israel. Indicated for use with manual compression as an adjunct to hemostasis for control of bleeding during adult liver surgery and soft tissue bleeding in adults when control of bleeding by standard surgical methods of hemostasis is… | Ethicon, Inc. | Device | Class II | 1 |
| 8 Apr 2016 | Brilliance 64 Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. | Philips Medical Systems (Cleveland) Inc | Device | Class II | 4 |
| 8 Apr 2016 | SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement. Event 73870 | Name withheld | Device | Class II | 1 |
| 7 Apr 2016 | Rose Red Organic Ginger Steam Filter Bag & Organic Ground Ginger Steam packaged in a poly-lined corrugated carton; 40 lb case bulk pack 40 lbs Event 73967 | Name withheld | Food | Class II | 1 |
| 6 Apr 2016 | VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents. | Ortho-Clinical Diagnostics | Device | Class II | 2 |
| 6 Apr 2016 | EZ Slide Battery/line powered hydraulic table with removable leg section and 21” top slide General Purpose Surgical Table Skytron EZ Slide Operating Table General Purpose Surgical Table | Skytron, Div. The KMW Group, Inc | Device | Class II | 1 |
| 5 Apr 2016 | Germ Terminator, Toothbrush Steam Sterilization for Oral Health. Model GT100. The Germ Terminator uses steam heat to sanitize two manual toothbrushes or two toothbrush heads. Water is poured into a reservoir in the device's housing. The steam cycle is followed by a drying cycle. Event 74015 | Ceg Enterprises Llc | Device | Class II | 1 |
| 5 Apr 2016 | Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) is recommended for use as part of a panel of antibodies in the definition of tumors of proximal nephrogenic differentiation. | Leica Microsystems, Inc. | Device | Class II | 2 |
| 4 Apr 2016 | Whole Dried Yellow Fish in bulk cardboard box, unlabeled, Product of China --- Fish measured 6.5 - 7.5 inches in length Event 73898 | WD IMPORT AND EXPORT INC. | Food | Class I | 1 |
| 1 Apr 2016 | Various trauma and sports medicine instruments and implants. guide, surgical, instrument | Biomet, Inc. | Device | Class II | 14 |
| 31 Mar 2016 | American Surgical Delicot 15mm x 20mm Ref: 63-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges | American Surgical Company | Device | Class II | 91 |
| 31 Mar 2016 | Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number MT6XSM1.7.0), and 1.7.1 (Part Number MT6XSM1.7.1), CIVCO, Orange City, IA 51041 | Med Tec Inc | Device | Class II | 1 |
| 31 Mar 2016 | Topicort (desoximetasone) Cream USP, 0.05%, Packaged in 5 g Tubes, Professional Sample Only, Rx Only. Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: TaroPharma a division of Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC: 51672-5205-5. | Taro Pharmaceuticals U.S.A., Inc. | Drug | Class III | 1 |
| 31 Mar 2016 | LGD-Xtreme (ligandrol LGD-4033),capsules, 3 mg, 90-count bottle, Manufactured for Continuum Labs, Fort Lauderdale, FL Event 73698 | Invisiblu International LLC | Drug | Class II | 1 |
| 30 Mar 2016 | Wylwood Fresh Frozen Broccoli Cuts, NET WT. 16 OZ Code: A25335P and A15335P Dist By: Save-A-Lot Stores, Earth City, MO. Event 73714 | Alimentos Congelados, S.A. (Pinula) | Food | Class I | 1 |
| 29 Mar 2016 | Yogurt Super Soynuts packaged in 16 oz. plastic bags and packaged in holiday tins. Lee Seed Company, Inc., Inwood, Iowa. Event 73686 | Lee Seed Co Inc | Food | Class I | 1 |
| 29 Mar 2016 | Organic Auricularia auricular (Dried Mushroom Powder (Jelly Ear Mushroom). 60 kg 4 mil polyethylene bags inside plastic polyethylene black drum. Certified Organic by QAI - Made in USA. Aloha Medicinals Inc. 2300 Arrowhead Drive Carson City, NV 89706 Event 73707 | Aloha Medicinals, Inc. | Food | Class I | 1 |
| 28 Mar 2016 | Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single monitor mount, 27inch max. screen size | Skytron, Div. The KMW Group, Inc | Device | Class II | 1 |
| 25 Mar 2016 | The Plum 360 is a large volume infuser capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions. The Plum 360 infuser can deliver fluids over a broad range of infusion rates and is capable of Concurrent delivery from one or more rigid or flexible fluid containers. The… | Hospira Inc. | Device | Class II | 2 |
| 25 Mar 2016 | Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection | Becton Dickinson & Company | Device | Class II | 2 |
| 24 Mar 2016 | The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic steroid, in plasma. | Abbott Laboratories | Device | Class II | 1 |
| 24 Mar 2016 | Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C, Oxoid Ltd. For the rapid chromogenic detection of beta-lactamase activity in bacterial cells. in vitro diagnostic | Remel Inc | Device | Class II | 1 |
| 24 Mar 2016 | Dimension Vista 500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lots are affected. The Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and… | Siemens Healthcare Diagnostics Inc. | Device | Class II | 2 |
| 23 Mar 2016 | ORIS (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for DENTSPLY Professional, York, PA 17404, UPC D00513003001O | Akorn, Inc. | Drug | Class II | 3 |
| 23 Mar 2016 | AA USA Trading Inc. Ginger Slice Net Wt: 8 oz., AA USA Trading Inc. 47 Reid St. South River, NJ 08882 Event 73614 | AA USA Trading Inc. | Food | Class I | 1 |
| 22 Mar 2016 | Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. Intended for the qualitative identification by light microscopy of human calretinin molecule in paraffin sections. | Leica Microsystems, Inc. | Device | Class II | 1 |
| 22 Mar 2016 | AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST-9 Multiple Well Test Tray (Item (1001). Contents: 8 applicators to perform up to 72 skin tests. Perform a multi-site skin test to identify reactions to certain allergens using a non-invasive applicator that contains 70 different allergens and… Event 73664 | Medscience Inc | Device | Class II | 1 |
| 21 Mar 2016 | Laparotomy Pack, Part numbers 006268-8 and 007725-8. This is a custom convenience surgical instrument disposable kit. There are multiple component in this kit and the recalled item subject to recall is Medtronic Kerlix X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32" W/L. | Windstone Medical Packaging, Inc. | Device | Class II | 3 |
| 21 Mar 2016 | Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be used with the AngioVac Cannula. | Angiodynamics Inc. (Navilyst Medical Inc.) | Device | Class II | 2 |
| 18 Mar 2016 | 8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx only, Hospira Inc, Lake Forest, IL 60045, NDC 0409-6625-02 | Hospira Inc. | Drug | Class I | 1 |
| 18 Mar 2016 | Undisputed , all lot codes, Flavors: Blue Raspberry, 330 grams packed in 20oz HDPE White Plastic Container, The product was sold in white bottles with a white cap, containing forty (40) powder servings; 12 /case | Nubreed Nutrition, Inc | Food | Class II | 7 |
| 17 Mar 2016 | Label reads in part as: "Clight***Naranja*** Orange***CALORIE FREE ARTIFICIALLY FLAVORED DRINK MIX***TWO PACKAGES IN ONE***MAKES 1 LITER***NET: 0.49 oz*** Distributed by: Mondelez Puerto Rico, LLC, Montehiedra Office Center Suite 801, 9615 Ave. Los Romeros, San Juan PR 00926-7037***Made in Costa Rica" | Name withheld | Food | Class II | 4 |
| 15 Mar 2016 | STAT-Check Resuscitation Bag Manual Emergency Resuscitation Bag with Carbon dioxide gas analyzer Intended for use in various clinical situations to provide respiratory support in the presence of reversible apnea commonly associated with respiratory arrest. The device should only be used by personnel trained in CPR… Event 73766 | Ventlab LLC | Device | Class II | 1 |
| 15 Mar 2016 | cobas EGFR Mutation Test, v2 and cobas cfDNA Sample Preparation Hungarian Translation Instructions for Use | Roche Molecular Systems, Inc. | Device | Class II | 1 |
| 15 Mar 2016 | EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF used with an Olympus video system center, light source, documentation equipment monitors, Endo Therapy accessories and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum. | Olympus Corporation of the Americas | Device | Class II | 1 |
| 14 Mar 2016 | Vaxcel PICC with PASV Catheter Kit under the following labels: 1) 3F, UPN H965454350, Rx ONLY, 2) 4F, UPN M001454550, Rx ONLY & 3) 5F, UPN M001454700, Rx ONLY. The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not… | Navilyst Medical, Inc., an AngioDyamics Company | Device | Class II | 23 |
| 11 Mar 2016 | Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument. | Integra York PA, Inc | Device | Class II | 1 |
| 11 Mar 2016 | Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use, Medical Industry | MicroAire Surgical Instruments, LLC | Device | Class II | 1 |
| 11 Mar 2016 | Ceftriaxone for Injection USP, 250 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-611-01), and b) 10-count Vials per box (NDC 68180-611-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462… | Lupin Pharmaceuticals Inc. | Drug | Class III | 5 |
| 11 Mar 2016 | Zinc Oxide Powder (API) used in the manufacturing of dietary supplements . Event 73599 | Zochem Inc. | Food | Class III | 1 |
| 9 Mar 2016 | Amikacin Sulfate injection USP,1 gm/4 mL (250 mg/mL) 4mL vial, Rx only, Manufactured in Hungary For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454. Individual Pack NDC 0703-9040-01, Shelf Pack NDC 0703-9040-03 | Teva Pharmaceuticals USA | Drug | Class I | 1 |
| 8 Mar 2016 | Liko Universal SlingBars Universal SlingBar" 350, Universal SlingBar" 350 QRH, Universal SlingBar" 350 R2R, Universal SlingBar" 450, Universal SlingBar" 450 QRH, Universal SlingBar" 450 R2R, Universal SlingBar" 600 Universal SlingBar" 600 QRH Component of Liko Lifts Product Usage: Universal SlingBar” 350 It is… | Hill-Rom, Inc. | Device | Class II | 1 |
| 7 Mar 2016 | Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments | Integra LifeSciences Corp. | Device | Class II | 2 |
| 3 Mar 2016 | Curity Gauze Sponges, 16 ply 4" x 4" (10.2 cm x 10.2 cm), Sterile 10's in Soft Pouch; Item Number: 397310; Open mesh fabric intended to be used to inside the body or a surgical incision to control bleeding, absorb fluid, or protect organs. | Covidien LLC | Device | Class II | 13 |
| 22 Feb 2016 | Video Duodenoscope | Pentax Medical Company | Device | Class II | 1 |
| 19 Feb 2016 | Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T The product is used as an aid in the identification of Staphylococcus aureus from Culture Event 74140 | Integrated Science Systems Inc | Device | Class II | 1 |
| 18 Feb 2016 | 1) VITROS Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique Device Identifier No. 10758750002320, 20758750002327) and the 2)VITROS Immunodiagnostic Products Total Beta-hCG II Calibrators (Unique Device Identifier No. 10758750002337, 20758750002334); For quantitative measurement of human chorionic… | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 12 Feb 2016 | Oasis Foods Canola Fry Shortening, Net Wt. 35 LB (15.88), Distributed by: Oasis Foods, Inc. Hillside, NJ 07205, UPC 7 32146 10378 8 | Oasis Trading Co., Inc. | Food | Class II | 22 |
| 11 Feb 2016 | Morphine Sulfate 0.5 mg/mL, Preservative Free in 0.9% Sodium Chloride, Rx, total volume 1 mL, This is a compounded drug, CII, IV Use, syringe, Pharmakon Pharmaceuticals, NDC 45183-0322-78. | Pharmakon Pharmaceuticals | Drug | Class I | 1 |
| 10 Feb 2016 | RayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4.0, 4.5 and 4.7., designed for treatment planning and analysis of radiation therapy. | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 4 Feb 2016 | THE SAUSAGE MAKER SEASONING Dried Sausage Sticks under the following labels: 1) Net Wt 6.5 oz, 2) Net Wt 2 lbs, 3) Net Wt 25 lbs, 4) Dried Sausage Stick Kit, 5) Dried Sticks Assortment Kit | The Sausage Maker, Inc. | Food | Class I | 6 |
| 27 Jan 2016 | LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. Part numbers: V15-2-xxxxxx (includes software version 1 and version 2); V15-5-xxxxxx (inclues software version 4). The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care… | Physio-Control, Inc. | Device | Class II | 1 |
| 21 Jan 2016 | 0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18. | Baxter Healthcare Corp. | Drug | Class I | 4 |
| 20 Jan 2016 | Fruit Tartlets, lemon flavor, 9 - 0.53oz (15 g) tartlets - Net Wt. 4.8 oz (135 g). Manufactured in France. Distributed by Ouhlala Gourmet Corp. dba Buddy Fruits, Coral Gables, FL | Ouhlala Gourmet Llc | Food | Class II | 2 |
| 15 Jan 2016 | Universal Battery Charger II (UBC II) | The Anspach Effort, Inc. | Device | Class II | 1 |
| 15 Jan 2016 | Licorice Coughing Liquid (guaifenesin), 5%, 3.38 fl. oz. (100 ml), OTC, Manufactured by: Ma Ying Long Pharmaceutical Group Co., LTD, Wuhan, China; Distributed by: Master Herbs (USA) Inc., NDC 68511-0460-01 Event 73102 | Master Herbs, Inc./Li | Drug | Class I | 1 |
| 9 Jan 2016 | Black Ant, packaged in Big Box (20 small boxes / 4 capsules per box / 80 capsules total), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | R Thomas Marketing, LLC | Drug | Class I | 24 |
| 29 Dec 2015 | CapriSun fruit punch roarin'waters packaged in a blue and white box with pictures of fruit and white lettering. | Kraft Heinz Foods | Food | Class II | 6 |
| 23 Dec 2015 | Endoscope; ED-530XT Operation Manual 'Operation and Preparation' and 'Cleaning, Disinfection and Storage' | Fujifilm Medical Systems U.S.A., Inc. | Device | Class II | 5 |
| 21 Dec 2015 | Hip Preservation System Signature Series PreBent Burs under the following labels: 1) PreBent Spherical Bur, 5.5mm x 19cm Catalog Number HPS-HB11, 2) PreBent Polishing Bur, 5.5mm x 19cm Catalog Number HPS-HB12 and 3) PreBent Oval Bur, 6.0mm x 19cm Catalog Number HPS-HB13 The ConMed Hip Preservation System Signature… | ConMed Corporation | Device | Class II | 1 |
| 15 Dec 2015 | 0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0049-02 | Baxter Healthcare Corp. | Drug | Class I | 2 |
| 15 Dec 2015 | Triple Ginger Brew, 25.4 FL OZ (750 mL) glass bottles, SKU 51857 Bottles are sold individually; there are 9 bottles per case | Trader Joes Company | Food | Class III | 1 |
| 11 Dec 2015 | FUEL UP PLUS, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bottle WWW.FUELUPPILLS.COM | Reesna, Inc | Drug | Class I | 2 |
| 9 Dec 2015 | Pink Bikini capsules, (all colors and all strengths), packaged in 30-count bottle, Manufactured and Distributed by: Lucy's Weight Loss System (dba Waisted With Lucy), Arlington, TX 76010 | Lucy's Weight Loss (dba. Waisted With Lucy) | Drug | Class I | 2 |
| 3 Dec 2015 | LIPO ESCULTURA capsules, 250 mg, 60-count bottles, Distributed By: JAT Productos Naturales Corp., BROOKLYN, NY 11238, www.lipoesculturatreatment.com Event 72782 | Lipo Escultura Corp. | Drug | Class I | 1 |
| 23 Nov 2015 | SUPER HERBS 350 mg, 30 capsules per bottle. Event 73361 | Name withheld | Drug | Class I | 1 |
| 10 Nov 2015 | Philips Healthcare DigitalDiagnost stationary X-ray system | Philips Healthcare | Device | Class II | 2 |
| 28 Oct 2015 | Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0025-5833-02) and (b) 1 prefilled auto injector + 1 trainer (NDC 0024-5833-00), Rx Only, Manufactured for Sanofi-Aventis US, LLC Bridgewater, NJ 08807 A Sanofi Company | Sanofi-Aventis U.S. LLC | Drug | Class I | 2 |
| 16 Oct 2015 | Pea protein 85% dry powder in a 20 KG bag. Event 72600 | Prinova US LLC | Food | Class I | 1 |
| 6 Oct 2015 | Ducktrap Smoked Mussels in both 6oz and 16oz Tubs | Ducktrap River of Maine LLC | Food | Class II | 3 |
| 1 Oct 2015 | ABG-HM-1 Hummi Micro Draw Blood Transfer Device Product Usage: It is used for blood transfer and collection from Peripheral Arterial Line Catheters. Event 72350 | Name withheld | Device | Class I | 1 |
| 23 Sep 2015 | Pink Bikini Strong Formula capsules, 750 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010 | Lucy's Weight Loss (dba. Waisted With Lucy) | Drug | Class I | 3 |
| 6 Sep 2015 | Philips Healthcare Brilliance 64 Computed Tomography X-Ray System | Philips Healthcare | Device | Class II | 7 |
| 24 Aug 2015 | Thin and Slim Fataway Ultimate Stack with Chromium, packaged per 120 capsules. Distributed by Dale H Enterprises Inc. Lewisburg, PA 17837, www.fataway.org. | Novacare, LLC | Drug | Class I | 13 |
| 18 Aug 2015 | Actifuse ABX/Actifuse MIS System A bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Event 74125 | Apatech Limited | Device | Class II | 1 |
| 3 Jun 2015 | Smart Lipo Dietary Supplement capsules, 800 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011 | Name withheld | Drug | Class I | 2 |
| 18 Apr 2015 | Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, NDC 0187-4100-10. | Valeant Pharmaceuticals North America LLC | Drug | Class III | 2 |
| 23 Mar 2015 | Sedecal SA Mobile Diagnost w DR x-ray system Event 74106 | Sedecal USA, Inc. | Device | Class II | 1 |
| 20 Jan 2015 | Avastin (Bevacizumab) 2 mg/0.08 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St Suite J, Melbourne, FL 32901. | Pacifico National, Inc. dba AmEx Pharmacy | Drug | Class I | 2 |
| 18 Dec 2014 | The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. Event 70054 | Sysmex Corporation | Device | Class II | 1 |
| 24 Feb 2014 | Myriad handpiece Tissue morcellator | Nico Corp. | Device | Class II | 1 |