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High RiskFDA
Northern Fisheries Ltd.
Frozen Yellowfin Tuna Steak, 4 oz. and 6 oz., Keep Frozen, Imported/Distributed: Mical Seafood Inc., 10400 Griffin Rd, Suite #209, Cooper...
Seafood·1,052 affected·Dec 6, 2019
High RiskFDA
Northern Fisheries Ltd.
Frozen Yellowfin Tuna Loins, 5-8 lbs, Keep Frozen, Imported/Distributed: Mical Seafood Inc., 10400 Griffin Rd, Suite #209, Cooper City, F...
Seafood·200 affected·Dec 6, 2019
High RiskFDA
Northern Fisheries Ltd.
Frozen Yellowfin Tuna Ground Meat, Keep Frozen, Imported/Distributed: Mical Seafood Inc., 10400 Griffin Rd, Suite #209, Cooper City, Flor...
Meat & Poultry·1,251 affected·Dec 6, 2019
High RiskFDA
Karl Storz Endoscopy
Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC...
Respiratory Devices·27,165 affected·Dec 6, 2019
High RiskFDA
Medtronic Navigation, Inc.
Mazor X Surgical System Positioner Type II, REF: ASM0214-02
Surgical Devices·177 affected·Dec 5, 2019
High RiskFDA
Stryker Gmbh
Stryker T2 Alpha Delta Strike Plate IMN Instruments - part of the IMN Instruments System and is used to support insertion and withdrawal ...
Medical Devices·433 affected·Dec 5, 2019
High RiskFDA
White Castle Intl
White Castle Sliders - Jalapeno Cheese Sliders - Jalapeno Cheeseburgers, UPC 8298801106 (6pk Jalapeno Cheeseburger)
Dairy·894,078 affected·Dec 4, 2019
High RiskFDA
Nassau Candy Distributors, Inc.
NANCY ADAMS DARK CHOCOLATE Graham Crackers, NET WT 7.5 OZ (212G); UPC 618645275860; packaged in a brown paper bag with a clear window
Bakery & Grains·2,172 affected·Dec 4, 2019
High RiskFDA
White Castle Intl
White Castle Sliders - The Original Slider Hamburgers
Food·894,078 affected·Dec 4, 2019
High RiskFDA
Werner Gourmet Meat Snacks, Inc.
Jolly Rancher product is hard candies, individually wrapped in flexible plastic wrap, and package in plastic bag. Net weight 2 oz or 4.5 ...
Meat & Poultry·2,076 affected·Dec 4, 2019
High RiskFDA
Edney And Sellers, Ltd.
Lalamilo Farms Tropical Dreams Hawaiian Ice Cream - Strawberry Cheesecake. Sold in 3 gallon tubs, 1.5 gallon tubs, 5 L tubs, 8 oz. cup...
Dairy·3 affected·Dec 4, 2019
High RiskFDA
American Health Packaging
Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister cards), Rx Only, Packaged and Distributed by: American Health Pa...
Oral Drugs·973 affected·Dec 4, 2019
High RiskFDA
Slade Gorton & Company, Inc.
GOURMET BAY Haddock with Seafood Stuffing; 6oz; SELL BY 05/26/21; LOT# 100457657; KEEP FROZEN; Cooking Instructions: Oven: Preheat oven t...
Seafood·1,053 affected·Dec 3, 2019
High RiskFDA
Slade Gorton & Company, Inc.
GOURMET BAY Salmon Roast with Crabmeat Stuffing; SELL BY: 12/10/19; KEEP REFRIGERATED; Cooking Instructions: Remove product from package ...
Meat & Poultry·384 affected·Dec 3, 2019
High RiskFDA
Slade Gorton & Company, Inc.
GOURMET BAY Flounder with Crabmeat Stuffing; SELL BY: 12/11/19; KEEP REFRIGERATED; Cooking Instructions: Oven: preheat oven to 400 degree...
Meat & Poultry·570 affected·Dec 3, 2019
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.
Medical Devices·11 affected·Dec 3, 2019
High RiskFDA
Ge Healthcare, Llc
Lunar iDXA bone densitometer
Medical Devices·123 affected·Dec 3, 2019
High RiskFDA
Ge Healthcare, Llc
Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer
Medical Devices·123 affected·Dec 3, 2019
High RiskFDA
Exactech, Inc.
Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 10.5mm, REF 304-22-11 - Product Usage: The Equinoxe Shoulder System i...
Medical Devices·0 affected·Dec 3, 2019
High RiskFDA
Exactech, Inc.
Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 6.5mm, REF 304-22-07 - Product Usage: The Equinoxe Shoulder System is...
Medical Devices·2,910 affected·Dec 3, 2019
High RiskFDA
Ge Healthcare, Llc
Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer
Medical Devices·123 affected·Dec 3, 2019
High RiskFDA
Cornfusion Gourmet Popcorn, Llc
Caramel flavored Popcorn, packaged in poly lined bags, net wt. 7 oz. (198 g). No UPC code.
Snacks & Candy·12 affected·Dec 2, 2019
High RiskFDA
Ask Foods Inc
Jonah Crab Meat Stuffing 5 lb. (2.27 kg) Bulk Plastic Container,6 - 5 lb. containers per case , Keep Frozen
Meat & Poultry·400 affected·Dec 2, 2019
High RiskFDA
Cornfusion Gourmet Popcorn, Llc
Maple Bacon flavored Popcorn, packaged in poly lined bags, net wt. 7 oz. (198 g). No UPC code.
Snacks & Candy·11 affected·Dec 2, 2019
High RiskFDA
Cornfusion Gourmet Popcorn, Llc
Caramel Apple flavored Popcorn, packaged in poly lined bags, net wt. 7 oz. (198 g). No UPC code.
Snacks & Candy·9 affected·Dec 2, 2019
High RiskFDA
Ask Foods Inc
Belle Mar Stuffing 5 lb. (2.27 kg) Bulk Plastic Container,6 - 5 lb. containers per case , Keep Frozen
Frozen Food·400 affected·Dec 2, 2019
High RiskFDA
Preferred Pharmaceuticals, Inc
Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC 68788-7078-06), Mfg: Amneal Pharma...
Oral Drugs·316 affected·Dec 2, 2019
High RiskFDA
Jubilant Cadista Pharmaceuticals, Inc.
Amantadine Hydrochloride Tablets, 100 mg, 100-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee-247661, India; Mark...
Oral Drugs·1,824 affected·Dec 2, 2019
High RiskFDA
Polymer Technology Systems, Inc.
PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Reference Numbers 2700
Diagnostic Devices·44,448 affected·Dec 2, 2019
High RiskFDA
Thoratec Corp.
HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI or GTIN: 00813024010890, when connected to the He...
Cardiac Devices·13,871 affected·Dec 2, 2019
High RiskFDA
Degania Silicone, Ltd.
Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number: 102201101463MD {Medline code 55346) Monitor urinary outp...
Surgical Devices·2,080 affected·Dec 2, 2019
High RiskFDA
Medela Inc
Invia Foam Dressing Kit with FitPad - X-Large (3 pcs) SKU # 0876224. The Invia Foam Dressing Kit with FitPad consists of a foam pad, a...
Medical Devices·331 affected·Dec 2, 2019
High RiskFDA
Medical Action Industries, Inc. 306
Medical convenience trays and kits, labeled as: Medical Action Industries, Inc.: ***CVC*** Clear Sequence Change Kit, REF 77070B ***...
Medical Devices·9,924 affected·Dec 2, 2019
High RiskFDA
Polymer Technology Systems, Inc.
Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036
Medical Devices·44,448 affected·Dec 2, 2019
High RiskFDA
Aap Implantate Ag
aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00
Medical Implants·7 affected·Nov 28, 2019
High RiskFDA
Skidmore Sales & Distributing Co Inc
CBI BG 2280/45025, 50 lb. package, 1 poly bag in cardboard box, 1140496
Food·24,500 affected·Nov 27, 2019
High RiskFDA
Cell-nique Corp Dba Living Harvest At Hudson River Foods
Hodgson Mill Unbleached All-Purpose White Wheat Flour 5 Lb bags 001042 Best By 10-01-2020 005517 Best By 10-02-2020
Food·4,428 affected·Nov 27, 2019
High RiskFDA
Pfizer Inc.
25% Dextrose Injection, USP 2.5 grams (250 mg/mL) 10 mL Single-dose, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-1775-10
Injectable Drugs·77,100 affected·Nov 27, 2019
High RiskFDA
Flexicare Medical Ltd.
BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3, CE 0120, Do not Re-use, Rx Only, REF, 040-333U, Sterile EO, Qty 10, (01)150...
Medical Devices·1,024,890 affected·Nov 27, 2019
High RiskFDA
Flexicare Medical Ltd.
BriteBlade Pro Single-se Fiber Optic Miller 2, CE 0120, Do not Re-use, Rx Only, REF, 040-722U, Sterile EO, Qty 10, (01) 15055788722783 ...
Medical Devices·1,024,890 affected·Nov 27, 2019
High RiskFDA
Flexicare Medical Ltd.
BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use, Rx Only, REF: 040-342U, Sterile EO, Qty 10, UDI:...
Medical Devices·1,024,890 affected·Nov 27, 2019
High RiskFDA
Edwards Lifesciences, Llc
QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705
Medical Devices·27,168 affected·Nov 27, 2019
High RiskFDA
Flexicare Medical Ltd.
BriteBlade Pro Single-Use Fiber Optic Mac 3, CE01120, Do Not Re-use, Rx Only, REF 040-713U, Sterile EO, Qty 10, (01)15055788723001 Th...
Medical Devices·1,024,890 affected·Nov 27, 2019
High RiskFDA
Ardent Mills Llc
Wild Harvest Organic Unbleached All Purpose Flour, Net Wt 5 lb. (2.26 kg) in paper bags, UPC 7 11535 50915 8, 8 bags per case.
Food·8,160 affected·Nov 26, 2019
High RiskFDA
Aquabest Seafood Llc
Sea Mart Frozen Yellowfin Tuna Loin, CO treated, skinless, boneless, bloodline removed, center cut 5-8 lbs, 30 lb package
Seafood·9,630 affected·Nov 26, 2019
High RiskFDA
Texas Star Nut And Food Co., Inc.
Great Value Macadamia Nuts 4 oz. pouch with UPC CODE: 078742309422 packaged in a cello bag, 6 per case
Food·4,332 affected·Nov 26, 2019
High RiskFDA
Aquabest Seafood Llc
Sea Mart Frozen Yellowfin Tuna Steak, CO treated, skinless, boneless, bloodline removed, 8 oz, 10lb package
Seafood·9,450 affected·Nov 26, 2019
High RiskFDA
Sca Pharmaceuticals, Llc
Lidocaine HCl 2% 5 mL, Syringe, Rx Only, SCA Pharmaceuticals 755 Rainbow Road Windsor, CT 08695 NDC 70004-0723-09
Drugs·1,363 affected·Nov 26, 2019