| 16 Aug 2019 | Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (concentration = 10 mg/mL), 6 mL Syringe, Rx Only, SCA Pharmaceuticals, Windsor, CT 06095, NDC 70004-0430-09. | SCA Pharmaceuticals, LLC | Drug | Class II | 1 |
| 9 Aug 2019 | Carbamazepine, Extended-Release Tablets, USP, 400 mg, 30 Tablets (3 blister cards x 10 unit doses), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-562-21; NDC Unit Dose: 68084-562-11 | American Health Packaging | Drug | Class II | 1 |
| 9 Aug 2019 | Dole Baby Spinach: 6 oz. (170 g) plastic bag, UPC 0-71430-00964-2, SKU 320; 10 oz. (283 g) clamshell, UPC 0-71430-00016-8, SKU 2337 Distributed by: Dole Fresh Vegetables, Inc., Monterey, CA 93940. | Dole Fresh Vegetables Inc | Food | Class I | 1 |
| 8 Aug 2019 | Nosh Organic Fruit & Protein Soft Oat Bar; Apple, Sweet Potato & Cinnamon. 6 - 0.74 oz. (21 g) bars per box. Net Wt. 4.44 oz. 126g) Ingredients: Organic Whole Grain Rolled Oats, Organic, Tapioca Syrup, Organic Sunflower Seed Protein, Organic Sunflower Oil, Organic Date Paste, Organic Sweet Potato Powder, Organic… | FIRST START HOLDINGS INC | Food | Class II | 2 |
| 8 Aug 2019 | Keto Farms Keto Snack Mix - Strawberry Gouda; Fruit & Cheese Mix with Sprouted Pecans & Almonds; Net Wt. 95 g (3.34 oz.) Ingredients: Gouda Cheese (Pasteurized Milk, Cheese Culture, Salt, Enzymes), Sprouted Organic Pecans, Sprouted Transitional Almonds, Strawberries, MCT Oil, Cold Water Sea Salt. Contains: Dairy… | Keto Farms LLC | Food | Class II | 3 |
| 7 Aug 2019 | Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%, 15 gram tubes, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Village: Kishanpura, Baddi Nalagarth Road, District: Solan, Himachal Pradesh-173205, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-298-17 | Glenmark Pharmaceuticals Inc., USA | Drug | Class III | 1 |
| 6 Aug 2019 | Amy's Bowls - Broccoli & Cheddar Bake; Net Wt. 9.5 oz. (269g) Perishable - Keep Frozen. Microwave or regular oven. UPC: 0 42272 00811 7 Amy's kitchen Inc., P.O. Box 7129, Petaluma, CA 94955 INGREDIENTS: RICE PASTA (ORGANIC RICE FLOUR, FILTERED WATER, ORGANIC POTATO STARCH, RICE STARCH, ORGANIC SOY FLOUR), ORGANIC… | Amys Kitchen Inc | Food | Class II | 1 |
| 5 Aug 2019 | FROZEN VAN YOG, in 3 gallon cardboard buckets | Belfonte Ice Cream & Dairy Foods Co | Food | Class II | 1 |
| 1 Aug 2019 | Entenmann's Little Bites Soft Baked Cookies (5 pack Mini Chocolate Chip variety) Net Weight of 5ct box 6.88oz. 5 pouches per package, package type is carton, units per case 12 | BIMBO Bakeries USA Inc. | Food | Class II | 1 |
| 1 Aug 2019 | Ginger Spice, 1 oz (28.4 g), 2 oz, 4 oz, and 1-3 lb packages. An herbal tea, Taos, NM | Milkweed & Monarch, LLC | Food | Class II | 3 |
| 30 Jul 2019 | Door County Whitefish Smoked Whitefish Pate 8oz plastic tub UPC 8 55356 00402 4 Keep Refrigerated 12 retail units per wholesale case Event 83481 | Ruleau Bros, Inc. | Food | Class I | 1 |
| 30 Jul 2019 | Taspen s Organics, Bedroom Bliss Herbal Tincture, Net wt 1 ounce, 2 ounce, 4 ounce | Green Water, LLC | Food | Class II | 7 |
| 29 Jul 2019 | Bexarotene Capsules, 75 mg, 100 capsules per bottle, Rx Only, Manufactured for: Upsher-Smith Laboratories, LLC, Maple Grove, MN 55369. NDC: 0832-0285-00 | Upsher Smith Laboratories, Inc. | Drug | Class II | 1 |
| 29 Jul 2019 | Batter mixes labeled the following ways: 1) Batter, Item Number 30713419.49, Net Wt. 50 lb, Distributed by Kerry Ingredients & Flavours, Beloit, WI 2) Batter, Item Number 30713419.TYS, Net Wt. 50 lb, Distributed by Kerry Ingredients & Flavours, Beloit, WI | Kerry, Inc | Food | Class II | 58 |
| 26 Jul 2019 | Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, packaged in a) 0.5 FL OZ (15 mL) bottle (UPC 6 78112 25415 6); b) 1 FL OZ (30 mL) bottle (UPC 6 78112 25419 4); c) 0.2 FL OZ (6 mL) bottle, Handy Pocket Pal (UPC 6 78112 25418 7); Distributed by Medtech Products Inc., Tarrytown,… | Medtech Products, Inc. | Drug | Class II | 14 |
| 26 Jul 2019 | Mariposa Farms Basil, Net Wt. 0.75 OZ, in plastic clamshell containers for retail sale. Mariposa Farms, Inc. Grinnell, IA Event 83431 | Mariposa Farms Inc | Food | Class II | 1 |
| 25 Jul 2019 | HS70A Diagnostic Ultrasound System Version 2.01.00, 2.01.01, 2.01.02, 2.01.03, 2.01.04, 2.01.05, 2.01.06, 1.00.06, 1.00.07, 1.00.08, 1.00.09, 1.00.10, 1.00.11, 1.00.12 | NeuroLogica Corporation | Device | Class II | 2 |
| 25 Jul 2019 | Fresh basil with Rock Garden brand label. Basil was packed in 1 lb. plastic bags and in 0.75 oz. clear plastic clamshell containers. Event 83496 | Herbs Unlimited d/b/a Rock Garden South | Food | Class II | 1 |
| 25 Jul 2019 | Organic Asian Sesame Ginger packets, 2.95 oz Event 83428 | Hyde & Hyde Inc | Food | Class II | 1 |
| 24 Jul 2019 | Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx Only, Distributed by: Alvogen, Inc. Pine Brook, NY 07058 USA, NDC 47781-303-01 | Alvogen, Inc | Drug | Class II | 2 |
| 24 Jul 2019 | SIGA Fresh Basil, 1 lb bag, 10 plastic bags (1 lb bag) per carton Event 83439 | SIGA LOGISTICS S DE RL DE CV | Food | Class II | 1 |
| 24 Jul 2019 | Hannaford brand 20 oz. traditional quiche w/tomatoes, cheese and basil in flexible plastic with round top and bottom. Event 83421 | Meninno Brothers Gourmet Foods | Food | Class II | 1 |
| 24 Jul 2019 | Tainy Vostoka brand Assorted Dry Fruits-Apple, net wt. 17.63 oz. (500gram) in clear plastic package marked with container code #21 01 19 SS and UPC #4605932006197. Event 83420 | Euphoria Fancy Food, Inc. | Food | Class I | 1 |
| 24 Jul 2019 | Great Value Mild Taco Seasoning, Net Wt. 1 OZ, Distributed by Wal-Mart Stores, Inc. Bentonville, AR. UPC 0 78742 24572v0 | CH Guenther & Sons, Inc | Food | Class I | 5 |
| 23 Jul 2019 | Mometasone Furoate Cream USP, 0.1%, packaged in a) 15gram tubes (NDC 68462-192-17) and b) 45 gram tubes (NDC 68462-192-55), Rx Only, Manufactured by; Glenmark Pharmaceuticals Ltd At: Village: Kishanpura, Baddi Nalagari Road, District: Solan, Himachal Pradesh -173205, India Glenmark Pharmaceuticals Inc., USA Mahwah,… | Glenmark Pharmaceuticals Inc., USA | Drug | Class II | 1 |
| 22 Jul 2019 | DeRoyal Enteral Safe Feeding Tubes: a) REF 54-2450R, 5 FR x 24" Polyurethane b) REF 54-2465R, 6.5 FR x 24" Polyurethane c) REF 54-2480R, 8 FR x 24" Polyurethane d) REF 54-3680R, 8 FR x 36" Polyurethane Product Usage: Feeding tube | DeRoyal Industries Inc | Device | Class II | 1 |
| 22 Jul 2019 | Acetylcysteine 2% Otic Drop, 15 mL bottle, Rx only, Refrigerate, Compounded by Wise Pharmacy, Littleton, CO 80123. | Wise Pharmacy | Drug | Class II | 11 |
| 19 Jul 2019 | MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer. | Cincinnati Sub-Zero Products LLC, a Gentherm Company | Device | Class III | 1 |
| 19 Jul 2019 | ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use. | Aniara Diagnostica LLC | Device | Class II | 2 |
| 19 Jul 2019 | Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulating tissue during general surgery, neurosurgery, ENT surgery, OB/GYN surgery, and maxillofacial / plastic surgery procedures. Model # 8145100S | Integra LifeSciences Corp. | Device | Class II | 1 |
| 19 Jul 2019 | The Cookie Dough Cafe - Chocolate chip chilled gourmet edible cookie dough; 1.6 oz bars, packaged in plastic wrappers, 16 bars per wholesale case. UPC: 850947006418 Event 83432 | The Cookie Dough Cafe | Food | Class I | 1 |
| 19 Jul 2019 | Archer Farms egg salad packaged in 12oz plastic cup with lid, 6 cups per case, refrigerated | Elevation Foods | Food | Class I | 4 |
| 18 Jul 2019 | SUNNYSIDE FARMS PRESTIRRED PEACH YOGURT WITH OTHER NATURAL FLAVORS, 6 OZ (170g) CUP;99% Fat Free UPC# 7-17544-20293-6 Distributed by Super Store Industries, P.O. Box 549, Lathrop, Ca 95330 Filled at Plant 06-26 Event 83382 | Super Store Industries-Turlock Dairy Division | Food | Class II | 1 |
| 18 Jul 2019 | Fennel Whole Seed was packaged in a clear plastic bag or poly-woven bags sold in bulk form, net weight ranges from 4 ounces to 50 pounds, sold under Mountain Rose Herbs brand. The label is read in parts: "***Fennel Seed Whole ***NET WT *** Origin: Egypt *** MOUNTAIN ROSE HERBS***EUGENE, OR 97402 ***". Event 83371 | Mountain Rose Inc. dba Mountain Rose Herbs | Food | Class I | 1 |
| 18 Jul 2019 | Sunchy Malta Pasteurized Non-Alcoholic Cereal Beverage in 7oz bottles 4 or 6/pack Event 83407 | Sunshine Bottling Co, Inc. | Food | Class III | 1 |
| 17 Jul 2019 | Kit BD Max Check-Points CPO IVD EU; Catalog # 278102 | Becton Dickinson & Co. | Device | Class II | 19 |
| 17 Jul 2019 | Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bottle, Rx only, Manufactured by for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by: Lupin Limited, Pithampur, INDIA NDC 68180-518-01 | Lupin Pharmaceuticals Inc. | Drug | Class II | 1 |
| 17 Jul 2019 | Tamsulosin Hydrochloride Capsules, USP 0.4 mg Rx only a) 100 count (NDC 33342-159-11), b) 500 count (NDC 33342-159-15) and c) 1000 count (NDC 33342-159-44) bottles, Manufactured : Macleods Pharma USA, Inc Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himchal Pradesh, INDIA | Macleods Pharma Usa Inc | Drug | Class II | 1 |
| 17 Jul 2019 | Timolol-Latanoprost P-F (0.5/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRX NJ 1705 Route 46 West, Suite 4, Ledgewood, NJ 07852 (844) 446-6979 | Name withheld | Drug | Class II | 2 |
| 16 Jul 2019 | MED-RX POLYURETHANE FEEDING TUBES: a) 5Fr X 16" (40cm), REF 54-1650R b) 6.5Fr X16" (40cm), REF 54-1665R c) 5Fr X 24" (60cm), REF 54-2450R d) 6.5Fr X 24" (60cm), REF 54-2465R e) 8Fr X 24: (60cm), REF 54-2480R f) 8Fr X 36" (91cm), REF 54-3680R | Canadian Hospital Specialties | Device | Class II | 1 |
| 16 Jul 2019 | Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray system as follows: Azurion 3 M12, Azurion 3 M15, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20 Models: 722063, 722064, 722067, 722068, 722078, 722079. Product Usage: The Azurion series (within the limits of the used… | Philips North America, LLC | Device | Class II | 1 |
| 16 Jul 2019 | Macaroni and Cheese packaged in 4 lb plastic bags, 12 bags per case, frozen Event 83362 | Diversified Foods and Seasonings LLC | Food | Class II | 1 |
| 15 Jul 2019 | Dimension Ferritin (FERR) Flex reagent cartridge DM FERR Product Usage: The FERR Flex reagent cartridge is intended to be used on the Dimension RxL clinical chemistry system to quantitatively measure ferritin in human serum and plasma. Measurements of ferritin aid in the diagnosis of diseases affecting iron… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 15 Jul 2019 | CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/5 mL Oral Solution, Antihistamine, Mixed Berry Flavor, 20 Single-Use Vials per Carton, 0.17 fl. oz. (5 mL) Each, 3.4 fl. oz. (100 mL) Total Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, NDC 69842-261-01 UPC… | Unipharma, Llc. | Drug | Class II | 3 |
| 12 Jul 2019 | Maximum Pelvic Trainer (MPT) Event 83328 | Ralston Group | Device | Class II | 1 |
| 12 Jul 2019 | Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone 1 mg/g Ophthalmic Ointment, 3.5 g tube, Rx only, Manufactured for H.J. Harkins Company, Inc. dba Pharma Pac by Perrigo Co, Allegan, MI 49010, NDC 52959-0407-01 | H J Harkins Company Inc dba Pharma Pac | Drug | Class II | 1 |
| 12 Jul 2019 | Asma Aid Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | Name withheld | Drug | Class II | 43 |
| 12 Jul 2019 | 48533 MDM 10200917, Double Dutch Muffin, pre - deposited - unbaked - keep frozen, UPC 10035074485337, Net Wt. 25.3 lbs, Manufactured by CSM Bakery Products NA, Inc. Tucker, GA | Brill, Inc., a CSM Bakery Solutions Company - Atlanta Ingredients | Food | Class II | 2 |
| 12 Jul 2019 | Buffalo Burgers ( 100% Pure Canadian Bison Meat ), Net Weight 16 oz. (1 lb ) 4 - 113 g Patties - individually frozen / per container / Box Event 83338 | Northfork Bison Distributions Inc. | Food | Class I | 1 |
| 12 Jul 2019 | Golden Macadamia Nuts Dry Roasted Style 4R-DM; 25 lb. cardboard box Product of Kenya Manufactured by Golden Peanut Company, LLC-Lodi 1230 S. Fairmont Ave. Lodi, Ca 95240 Event 83379 | Golden Peanut and Tree Nuts LLC | Food | Class I | 1 |
| 11 Jul 2019 | CVS Health Glycerin Suppositories, 50-count box, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. UPC 0 50428 33106 4 | US Pharmaceuticals Inc. | Drug | Class II | 18 |
| 11 Jul 2019 | Freshness Guaranteed Chocolate Chunk cookie Clear plastic clam shell Net wt. 14 oz. UPC: 0007874209234 Event 83335 | Hill & Valley Inc | Food | Class II | 1 |
| 11 Jul 2019 | Shirakiku FISH CAKE IWASHI TEN SK F 20/150 g; Net WT. 5.29 oz. Keep frozen, 7 pcs. UPC 074410925246 Distributed by Wismettac Asian Foods, Inc. Santa Fe Springs, CA | Wismettac Asian Foods, INC | Food | Class I | 8 |
| 10 Jul 2019 | IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128 | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 2 |
| 10 Jul 2019 | ABL90 FLEX Analyzer REF 393090 UDI:05700693930909 | Radiometer America Inc | Device | Class II | 1 |
| 10 Jul 2019 | Lantis 6.1 Commander, Model # 5493072 - Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to the patient using the mevatron and all available accessories. This entails selecting a patient, selecting today s treatment for that patient, setting up and delivering the treatment… | Siemens Medical Solutions USA, Inc | Device | Class II | 4 |
| 10 Jul 2019 | ClubMax Laser Projection Series | Gk Photonics Inc | Device | Class II | 6 |
| 10 Jul 2019 | Equate Night-time Sleep Aide (Diphenhydramine HCl), 50 mg, Alcohol Free, Berry Flavor, 12 Fl. Oz. (354 mL), OTC, Distributed by: Walmart Stores, Inc., Bentonville, AR 72716, NDC 49035-330-02, UPC 6 8113117595 1 | LNK International, Inc. | Drug | Class II | 1 |
| 9 Jul 2019 | Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (20 mm) 9630TF20 UDI:00690103201239 | Edwards Lifesciences, LLC | Device | Class I | 4 |
| 9 Jul 2019 | MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914 | Siemens Medical Solutions USA, Inc | Device | Class II | 4 |
| 9 Jul 2019 | Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each blister card contains 28-film coated, biconvex tablets, Rx Only, Manufactured by: Cyndea Pharma, S.L., Olvega (Soria), 42110 Spain, Distributed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury,… | Jubilant Cadista Pharmaceuticals, Inc. | Drug | Class I | 1 |
| 9 Jul 2019 | Dolfin Dark Chocolate with Pink Peppercorns Net Wt 2.47 oz (70g), UPC 5 413415 233300, bar code 1938090025 Event 83236 | Name withheld | Food | Class II | 1 |
| 8 Jul 2019 | VITROS 250 Chemistry System, clinical chemistry analyzer | Ortho Clinical Diagnostics | Device | Class II | 12 |
| 8 Jul 2019 | Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe, Rx only, packaged in a box containing one 1 mL syringe, Distributed by: Primal Critical Care, Inc., 3950 Schelden Circle Bethlehem, PA, 18017, NDC 66794-151-01 | Piramal Critical Care, Inc. | Drug | Class II | 1 |
| 3 Jul 2019 | Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System | Elekta Inc | Device | Class II | 1 |
| 3 Jul 2019 | SOMATOM Definition AS, Model Number 8098027 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images… | Siemens Medical Solutions USA, Inc | Device | Class II | 7 |
| 2 Jul 2019 | QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsymphony SP instrument is designed to perform automated purification of nucleic acids-IVD) Model Number: 9001297 Product Usage: The QIAsymphony SP instrument is designed to perform automated purification of nucleic acids. It is… | Qiagen Sciences LLC | Device | Class II | 1 |
| 2 Jul 2019 | Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151810 | Zimmer Biomet, Inc. | Device | Class II | 6 |
| 2 Jul 2019 | Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets (0.8 mg/0.025 mg) and Ferrous Fumarate, Chewable Tablets, Rx Only, Distributed by: Lupin Pharmaceuticals, Inc. Baltimore, MD - 21202 Manufactured by: Lupin Limited Pathampur -454775 India. NDC 68180-903-11 (wallet of 28 tablets) NDC 68180-903-13 (carton… | Lupin Pharmaceuticals Inc. | Drug | Class II | 1 |
| 1 Jul 2019 | Rusch EasyCath Kit | Teleflex Medical | Device | Class II | 1 |
| 1 Jul 2019 | STERILE GRAVES VAGINAL SPECULUM MEDIUM Kit Code # GVS10MST - Product Usage:The speculum is used to spread the walls of the vagina to facilitate examination. It is used by medical professionals in a clinical setting. | Centurion Medical Products Corporation | Device | Class II | 13 |
| 1 Jul 2019 | Bento Express Fully Cooked Pink Salmon in a Teriyaki Sauce with Snow Peas, Garnished with Sesame Seeds. Served on Steamed White Rice, UPC Code: 670452710149 Event 83248 | Name withheld | Food | Class II | 1 |
| 28 Jun 2019 | Cardinal Health Jackson-Pratt Channel Drain 15FR Cardinal PN:JP-2223 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic… | Degania Silicone, Ltd. | Device | Class II | 8 |
| 28 Jun 2019 | Workstation, G2, Configured (P/N 000-0241) Event 83299 | Intellijoint Surgical, Inc. | Device | Class II | 1 |
| 28 Jun 2019 | Green Giant Fresh Cauliflower Sweet Potato Crumbles; Chopped Sweet Potato and Cauliflower 1 lb.(16 oz.) (454 g) plastic bag UPC: 605806000515; Item number MXC100101 Perishable, Keep Refrigerated Distributed by Growers Marketing LLC, Salinas, CA | Name withheld | Food | Class II | 13 |
| 27 Jun 2019 | AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following an anatomies/procedures: positioning fluoroscopy procedures, gastro-intestinal examinations,… Event 83400 | Name withheld | Device | Class II | 1 |
| 27 Jun 2019 | N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in serum, plasma, urine and CSF. Siemens Material Number (SMN):10446539 | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 26 Jun 2019 | SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014 | MicroAire Surgical Instruments, LLC | Device | Class II | 1 |
| 25 Jun 2019 | K-Wire HBS Sterile, Item Number 19688 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine. | BioPro, Inc. | Device | Class II | 21 |
| 25 Jun 2019 | Smart Sense Regular Strength Aspirin Tablets, 325 mg packed in a) 100 count UPC 8-8397-38781-6 and b) 500 count UPC 8-83967-38786-1 bottles, Distributed by: Kmart Corporation Hoffman Estates, IL 60179 | AAA Pharmaceutical, Inc. | Drug | Class III | 1 |
| 24 Jun 2019 | VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to hospital protocols on adults, pediatrics and… | Fenwal Inc | Device | Class I | 2 |
| 24 Jun 2019 | Ingenuity CT, Model # 728326, computed tomography x-ray system | Philips Medical Systems (Cleveland) Inc | Device | Class II | 9 |
| 21 Jun 2019 | A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (M-21 SERIES)- Temporary Pacing Electrode as follows: 021-001 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) 021-010 MYO/Wire Ultra-Flex Monopolar (Org.,2-0) 021-011 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) Used as a connection between… | Alto Development Corp | Device | Class II | 1 |
| 20 Jun 2019 | ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs) | St Jude Medical Inc. | Device | Class I | 6 |
| 20 Jun 2019 | Truly Good Foods Edamame Beans Roasted and Salted 7 oz. (198g) plastic clam shell DISTRIBUTED BY TRULY GOOD FOODS, CHARLOTTE, NC 28273 UPC 0 94184 56100 6 | Tropical Nut & Fruit Company | Food | Class II | 1 |
| 19 Jun 2019 | iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2 | Elekta, Inc. | Device | Class II | 1 |
| 19 Jun 2019 | Ascorbic Acid 500 MG/ML (Non-Corn) Injection (PFV), 50 mL per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0173-10 | RXQ Compounding LLC | Drug | Class II | 86 |
| 18 Jun 2019 | Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100 | Howmedica Osteonics Corp. | Device | Class II | 1 |
| 18 Jun 2019 | LSB Style Anchor Bolt. Labeled with the following parts: 13mm anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap, 21mm anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap, 13mm non-anodized anchor bolt body with anchor bolt cap containing a… | Ad-Tech Medical Instrument Corporation | Device | Class II | 1 |
| 18 Jun 2019 | Penafiel Mineral Spring Water 600mL (20.3 FL OZ) and Penafiel Mineral Spring Water 1.5 L (50.7 FL OZ) packaged in clear PET bottles, 12 units per case UPC 078000200249 and 078000200294 Event 83145 | Mott's LLP | Food | Class III | 1 |
| 17 Jun 2019 | VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 14 Jun 2019 | Acuject Variable Injection Needle | Wilson-Cook Medical Inc. | Device | Class II | 1 |
| 14 Jun 2019 | Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE | Terumo Cardiovascular Systems Corporation | Device | Class II | 4 |
| 12 Jun 2019 | BD Vacutainer Lithium HeparinN (LH) 37 USP Units Blood Collection Tubes, Catalog Number 366664 | Becton Dickinson & Company | Device | Class II | 15 |
| 12 Jun 2019 | Oxytocin 60 units/1000 mL Lactated Ringers Intravenous Solution, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Infusion Options, Inc. | Drug | Class II | 76 |
| 11 Jun 2019 | Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is for the control of accuracy. | Randox Laboratories, Limited | Device | Class II | 1 |
| 10 Jun 2019 | Luer Lock Set - Catalog # MPC-125, for IV administration sets. | Molded Products Inc | Device | Class II | 1 |
| 10 Jun 2019 | VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory instrument to ANY 5mm spot suction/irrigation catheter Event 83051 | Santanello Surgical LLC | Device | Class II | 1 |
| 10 Jun 2019 | Assayed Bovine Multi-Sera Level 1, Model No. AL1027 | Randox Laboratories, Limited | Device | Class III | 1 |
| 7 Jun 2019 | Sheridan Endotracheal Tube contained inside Centurion kit code TC7855. | Centurion Medical Products Corporation | Device | Class I | 1 |
| 7 Jun 2019 | PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 1710 Product Usage: PTS Panels Lipid Panel test strips measure total cholesterol, HDL (high density lipoprotein) cholesterol, and triglycerides in whole blood with the CardioChek PA or the CardioChek Plus professional analyzers, and provide a… | Polymer Technology Systems, Inc. | Device | Class III | 2 |
| 7 Jun 2019 | Frontal Stretch Buckle Closure Apron, Product Number A-10, Part Numbers REA10A, REA10B, REA10C, REA10*F, REA10*M, UEA10*M Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of… | Burlington Medical, LLC | Device | Class II | 24 |
| 7 Jun 2019 | Kirkland Signature Three Berry Blend product, frozen, package in a plastic bag. Net wt. 4 lbs. UPC 0 96619 10105 4. The product label is read in parts: "*** KIRKLAND Signature *** Three Berry Blend *** Raspberries***Blueberries***Blackberries*** PRODUCT OF USA *** Distributed by: Costco Wholesale Corporation ***". | Townsend Farms Inc | Food | Class I | 1 |
| 7 Jun 2019 | PRIVATE SELECTION FROZEN TRIPLE BERRY MEDLEY, 48 oz | The Kroger Co | Food | Class I | 3 |
| 5 Jun 2019 | Filter-Tips, 1500 ul (1024 tips/kitbox), REF 997024- REF: 997024 IVD: Used with the QIAGEN QIAsymphony SP/AS Instruments (REF 9001297 and 9001301) REF: 997024 Used in sample preparation | Qiagen Sciences LLC | Device | Class I | 1 |
| 3 Jun 2019 | SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box of 20 | Suntech Medical, Inc. | Device | Class II | 1 |
| 30 May 2019 | BD Vacutainer Fluoride Tubes for Blood Alcohol determinations Part Number: 367001 Product Usage: Blood Alcohol determinations | Becton Dickinson & Company | Device | Class II | 1 |
| 29 May 2019 | SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System | Pega Medical Inc. | Device | Class II | 1 |
| 29 May 2019 | Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as an aid in the diagnosis of acute myocardial infarction (AMI). | Siemens Healthcare Diagnostics Inc | Device | Class II | 1 |
| 29 May 2019 | Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform peritoneal dialysis (APD) in conjunction with the Liberty cycler as follows: (1) LIBERTY Line Cycler Set with Stay-safe connectors (Dual Patient Connector) Part Number: 050-87212 (2) LIBERTY Line Cycler Set with Stay-safe… | Fresenius Medical Care Renal Therapies Group, LLC | Device | Class II | 1 |
| 27 May 2019 | "DEEP***GOLDEN RAISINS***NET WT***198g/7oz***DEEP FOODS, INC. UNION, NJ 07083" | Deep Foods Inc | Food | Class I | 1 |
| 21 May 2019 | The Alinity ci-series System Control Modules which are configured with Alinity c Processing Modules. The Alinity ci-series Control Module is labeled in part,"* * *Alinity ci-series* * *SYSTEM CONTROL MODULE Product Usage: The Alinity ci series System Control Module has a scalable design to provide full integration of… | Abbott Gmbh & Co. KG | Device | Class II | 1 |
| 21 May 2019 | DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usage: The Salivary Testosterone ELISA (SlV-3013) is an enzymatic in vitro Assay for the detection of Testosterone in human Saliva. Testosterone levels are measured in fertility studies in men and women.… | DRG Instruments GmbH | Device | Class II | 1 |
| 20 May 2019 | The Visibly Online Refractive Vision Test which is part of the Visibly Vision Test Solution, This is a software application that partners and their customers were given access to. Product Usage: This online portion of the Visibly Vision Test Solution is used to measure vision refraction. Event 83298 | Opternative Inc | Device | Class II | 1 |
| 16 May 2019 | GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm). | Codman & Shurtleff Inc | Device | Class II | 1 |
| 16 May 2019 | GE Senographe Pristina - Product Usage: Senographe Pristina generates digital mammographic images that can be used for screening and in the diagnosis of breast cancer. Senographe Pristina is intended to be used in the same clinical applications as traditional film-based mammographic systems. | GE Healthcare, LLC | Device | Class II | 2 |
| 10 May 2019 | Centurion Convenience Kits, containing BD Alaris Pump Infusion Sets. BD code 11522558 (Centurion code 110931) contained inside kits DYNJ52509A and DYNJ52510A. Product Usage: The Centurion Primary Set Pack and Primary Warmer Pack Convenience Kit helps continuously or intermittently deliver fluids, medications, blood… | Medline Industries Inc | Device | Class I | 1 |
| 8 May 2019 | Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only Product Usage: The Assurance Nasal Alar SpO2 Sensor is indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and pediatric patients,… Event 82817 | Xhale Assurance, Inc. | Device | Class II | 1 |
| 3 May 2019 | Medline Primary Warmer Pack, Product No. DYNJ52510A. The Medline Primary Warmer Pack contains the recalled Vyaire enFlow Disposable Cartridge, which is the subject of this recall, and the recalled BD Alaris Pump Infusion Set (RES#82951) Product Usage: The Vyaire enFlow Disposable Cartridges contain a heating element… | Medline Industries Inc | Device | Class I | 1 |
| 2 May 2019 | EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 10G - REF ECP0110G. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities. | Bard Peripheral Vascular Inc | Device | Class II | 6 |
| 2 May 2019 | SenTec Membrane Changer (reloadable) [9 pcs] - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension… | SenTec AG | Device | Class II | 5 |
| 29 Apr 2019 | Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIZ CVx, Affiniti 30, Affiniti 50, and Affiniti 70. Product Usage: The intended use of the EPIQ, EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound Systems… | Philips Ultrasound Inc | Device | Class II | 1 |
| 26 Apr 2019 | Inovo Single Luman Conserver Product Usage: This device is intended to regulate the flow of oxygen from an oxygen tank and only deliver oxygen as the patient inhales, resulting in greater efficiency and cost saving ratios. | Inovo, Inc | Device | Class II | 1 |
| 25 Apr 2019 | Lidar System for Erosion Flume Application Class 1 Laser Product Product Usage: Product is installed and fixed above a dynamic indoor flume designed for modeling water erosion in an indoor research environment with limited human access Event 83302 | ASTRA, LLC | Device | Class II | 1 |
| 25 Apr 2019 | Endoscopic Cleaning Brushes sold in various Endoscopy Kits - Product Usage: The brushes are used to help clean out the endoscopes in between patient procedures. | Medline Industries Inc | Device | Class II | 1 |
| 24 Apr 2019 | DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's Laboratories Ltd. Bachupally - 500 090 India. Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152. NDC # 0904-6363-61. | MAJOR PHARMACEUTICALS | Drug | Class II | 1 |
| 12 Apr 2019 | Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.25g, For single use only, Part Number 20115 - Product Usage: Augmentation or reconstructive treatment of the alveolar ridge; Filling of infrabony periodontal defects; Filling of defects after root resection, apicoectomy and cystectomy;… | Geistlich Pharma North America, Inc. | Device | Class II | 3 |
| 11 Apr 2019 | BALQEES SPICES, Yemeni Spices Mix, NET WEIGHT: 230g (1/2 lb.) and 454 grams (1lb.) clear plastic container and 5 lbs. clear plastic bag. Distributed By: Makzemo LLC, 7304 5th Avenue # 112, Brooklyn, NY 11209, (718) 219-6630, Ingredients, Turmeric, Black Pepper, Cumin, Coriander, Garlic, Flavors Event 83536 | Makzemo LLC | Food | Class I | 1 |
| 1 Apr 2019 | Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible endoscopes include Olympus bronchoscopes,… | Olympus Corporation of the Americas | Device | Class II | 1 |
| 1 Apr 2019 | Accent Care of New York Home Care Nursing Personal Care Hand Sanitizer (Ethyl Alcohol 62%), 0.33 oz/10 mL, OTC, Made in China | NingBo Huize Commodity Co.,Ltd. | Drug | Class III | 36 |
| 30 Mar 2019 | Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System | Thoratec Corp. | Device | Class II | 2 |
| 21 Mar 2019 | Regard custom surgical pack labeled as "LAP - FLOL LADY OF ANGELS" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP. | ROi Consolidated Service Center (CSC) | Device | Class II | 2 |
| 18 Mar 2019 | IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes: 210cc, 240cc, 270cc, 300cc, 335cc, 370cc, 405cc, 440cc, 475cc, 515cc, 555cc, 595cc, 635cc, and 675cc. Event 83251 | Ideal Implant Incorporated | Device | Class II | 1 |
| 13 Mar 2019 | 14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061423 Product Usage: An aid for introducing a hemodialysis catheter | Medical Components, Inc dba MedComp | Device | Class II | 3 |
| 1 Mar 2019 | Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg, 20 capsules per carton (5 blister cards x 4 unit doses), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-305-32; NDC Blister Pack: 60687-305-33 | American Health Packaging | Drug | Class II | 1 |
| 26 Feb 2019 | CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible | Biomet 3i, LLC | Device | Class II | 5 |
| 20 Feb 2019 | Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452 | Luminex Corporation | Device | Class II | 7 |
| 19 Feb 2019 | Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-316-00) and b)1000-count bottles (NDC 68001-316-08), Rx Only, Manufactured by: Lupin Limited, Goa 403 722 INDIA For BluePoint Laboratories. | American Health Packaging | Drug | Class III | 1 |
| 28 Jan 2019 | ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869030005 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver),… | Siemens Medical Solutions USA, Inc. | Device | Class II | 4 |
| 5 Dec 2018 | Toothete Oral Care Sodium Bicarbonate Mouthpaste, Net Wt. 1/3 oz/ 9g, included in Independent Care System. The system is an oral care convenience kit which includes: an Ultra-Soft Toothbrush, 0.5 oz. tube of Mouth Moisturizer, 0.33 oz. /9g tube of Sodium Bicarbonate Mouthpaste and 1.5fl.oz. bottle of Corinz oral… | Sage Products Inc | Device | Class II | 1 |
| 30 Nov 2018 | Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2 | Philips Medical Systems Nederlands | Device | Class II | 1 |
| 21 Nov 2018 | Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of ferritin in human serum and plasma on the Alinity i analyzer. | Abbott Ireland Diagnostics Division | Device | Class II | 1 |
| 16 Oct 2018 | MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the following implant types: a. Mil000 CONCERTO PIN +FLEX28; b. Mi1000 CONCERTO +FLEX28; c. Mi1000 CONCERTO PIN +FLEXsoft; d. Mil000 CONCERTO +Standard; e. Mil000 CONCERTO +Medium; f. Mi1000 CONCERTO PIN +Standard; g. M11000 CONCERTO +Compressed… | MED-EL Elektromedizinische Gereate, Gmbh | Device | Class II | 3 |
| 1 Oct 2018 | YXLON Cheetah cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control | Comet Technologies Usa Inc | Device | Class II | 2 |
| 25 Sep 2018 | PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX Battery Pack, 40 Pouches - PDBP-040-2 Product Usage: -The PDBP-001 Battery is a single use (non-rechargeable) sterile lithium ion battery accessory that powers the PDSD Surgical driver. There is only one PDSD… | Pro-Dex Inc | Device | Class II | 1 |
| 19 Sep 2018 | Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P. | Encore Medical, Lp | Device | Class II | 1 |
| 11 Sep 2018 | TiLite X-Short anti-tip tubes, models TRA, AERO T, ZRA, AERO Z, 2GX, AERO X, Twist, and AERO R, a component of the TiLite wheelchair (anti-tip extension for manual wheelchairs). Product Usage: The affected component is part of a manual wheelchair to provide mobility to physically impaired individuals. The affected… Event 83360 | TiSport, Llc | Device | Class II | 1 |
| 1 Aug 2018 | Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit Dose Blisters), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217, NDC Carton: 62584-693-21; NDC Unit Dose: 62584-693-11 | American Health Packaging | Drug | Class II | 1 |
| 26 Jul 2018 | Microdot Xtra blood glucose test strips Event 82867 | Cambridge Sensors Limited | Device | Class II | 1 |
| 29 Jun 2018 | Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling: JADAK JDK-2330 REV B 170512-017 | Luminex Corporation | Device | Class II | 1 |
| 19 Mar 2018 | HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only. HYTEC AUTOSTAT II RF assays: HYTEC AUTOSTAT II RF IgM Kit: Part Number FGA 05, HYTEC AUTOSTAT II RF IgA Kit: Part Number FGA 06, HYTEC AUTOSTAT II RF IgG Kit: Part Number FGA 07, HYTEC AUTOSTAT II Total… Event 83268 | Hycor Biomedical Inc | Device | Class II | 1 |
| 21 Feb 2018 | AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor IgM ELISA is intended to be utilized as either a manual or an automated procedure The Intended Use is as follows: Enzyme-linked immunosorbent assay method for the semi-quantitative determination of specific IgM Rheumatoid Factor… Event 82952 | Hycor Biomedical Inc | Device | Class II | 1 |
| 15 Feb 2018 | The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascularly through a catheter to occluded lesions in the peripheral arteries to cross them. The system is a self-contained unit that consists of a light source unit and a single use catheter. The light source contains a microprocessor… | Ra Medical Systems Inc | Device | Class II | 1 |
| 16 Mar 2015 | Brand Name Burn Navigator Model Numbers: Catalog 1120, Burn Navigator H2 Catalog 1125, Burn Navigator H2 Transport Package Burn Navigator User Manual Manual-1120 Burn Navigator User's Manual, Rev. F Battery: Panasonic Model CF-H2 Part Number CMP-1523 Event 81594 | Arcos, Inc | Device | Class II | 1 |