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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
CriticalFDA
Lin's Waha International Corp.
Bingtangyangmei Waxberry, 8.11 OZ (230g) clear plastic containers, UPC 6948576407219 and date 02.13.2020 stamped on the box
Produce·50 affected·Dec 3, 2019
CriticalFDA
Onset Worldwide
Onset Worldwide, Nitro-Milled Black Chia, Unit size: 50 lb Bulk
Food·500 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
CriticalFDA
Dole Fresh Vegetables Inc
Tri-Color Coleslaw - Marketside brand; 16 oz. plastic bag, SKU 3117 Colorful Coleslaw/Salade de Chou - President's Choice Brand - ...
Produce·3,117 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
Medium RiskFDA
Auromedics Pharma Llc
Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For Topical Ophthalmic Use Only, Distributed by: Aurobindo Phar...
Topical Drugs·100,080 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
CriticalFDA
Middlefield Original Cheese Coop
Shredded Parmesan Cheese Packaged in plastic 5lb bags, 4 bags per box
Dairy·80 affected·Nov 29, 2019
CriticalFDA
Middlefield Original Cheese Coop
Shredded Cheddar Cheese Packaged in plastic 5lb bags, 4 bags per box
Dairy·920 affected·Nov 29, 2019
CriticalFDA
Laubscher Cheese Company, Ltd.
Laubscher Cheese Co.; Shredded Cheese; Net Wt. 5 LBS. and 2 LBS.,Cryovac sealed plastic bags, Distributed By: Laubscher Cheese Co. Mercer...
Dairy·1,617,420 affected·Nov 29, 2019
CriticalFDA
Middlefield Original Cheese Coop
Shredded Mozzarella/Provolone Mix Cheese Packaged in plastic 5lb bags, 4 bags per box
Dairy·1,100 affected·Nov 29, 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
CriticalFDA
Fuji Food Products, Inc.
Trader Joe's 8pc Tempura Shrimp Crunch Roll, 8.5oz, SKU 513289
Seafood·75,821 affected·Nov 26, 2019
CriticalFDA
Fuji Food Products, Inc.
Okami brand 8pc Supreme Sampler, SKU 28112
Food·75,821 affected·Nov 26, 2019
CriticalFDA
Fuji Food Products, Inc.
Trader Joe's 8pcs Regular California Roll, 8oz, SKU 00348997T
Food·75,821 affected·Nov 26, 2019
CriticalFDA
Fuji Food Products, Inc.
Trader Joe's 10oz Banh Mi Style Salad w/ Tofu, SKU 614719
Produce·75,821 affected·Nov 26, 2019
CriticalFDA
Fuji Food Products, Inc.
Trader Joe's Shrimp Spring Rolls 7oz, SKU 908795
Seafood·75,821 affected·Nov 26, 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
CriticalFDA
Fuji Food Products, Inc.
Trader Joe's 8pcs Spicy California Roll, 8oz, SKU 00348966T
Food·75,821 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
CriticalFDA
Fuji Food Products, Inc.
Trader Joe's 8pcs Smoked Salmon Philly Roll, SKU 603775
Seafood·75,821 affected·Nov 26, 2019
CriticalFDA
Fuji Food Products, Inc.
Trader Joe's 8pcs Brown Rice California Roll, 8oz, SKU 909822
Food·75,821 affected·Nov 26, 2019