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CriticalFDA
Heartware, Inc.
Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US, 1511AR, 1511AU, 1511BR, 1511CA, 1511CH, 1511DE, 1511GB, 15...
Medical Devices·3,283 affected·Feb 26, 2021
CriticalFDA
Kareem Mart Inc
Tahina Sesame Paste packaged in 1lb and 2lb plastic jars and 10kg metal containers; UPC CODES 6215000382207
Food·1,800 affected·Feb 25, 2021
CriticalFDA
Biomedical Equipment Service Co (bmes)
Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part ...
Medical Devices·718 affected·Feb 25, 2021
CriticalFDA
Tenacore Llc
Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410
Medical Devices·1,494 affected·Feb 25, 2021
CriticalFDA
Mediterranean Food, Inc.
Alqosh Sesame Oil "Tahin" packaged in 2lb plastic jars
Food·140 affected·Feb 24, 2021
CriticalFDA
Zydus Pharmaceuticals (usa) Inc
Acyclovir Sodium Injection 1000mg/20mL (50mg/mL) vial NDC 68382-049-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packa...
Injectable Drugs·816 affected·Feb 18, 2021
CriticalFDA
Zydus Pharmaceuticals (usa) Inc
Acyclovir Sodium Injection 500mg/10mL (50mg/mL) vial NDC 68382-048-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packag...
Injectable Drugs·1,638 affected·Feb 18, 2021
CriticalFDA
Smisson-cartledge Biomedical, Llc
ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for i...
Medical Devices·7,118 affected·Feb 18, 2021
CriticalFDA
Smisson-cartledge Biomedical, Llc
ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for i...
Medical Devices·11,768 affected·Feb 18, 2021
CriticalFDA
El Abuelito Cheese, Inc.
Quseo Fresco sold under the following brands and container sizes - El Abuelito Cheese Brand - Queso Fresco Regular 12 oz.Plastic Contai...
Dairy·0 affected·Feb 17, 2021
CriticalFDA
El Abuelito Cheese, Inc.
Quesillo sold under the following brands and container sizes: El Abuelito Cheese Quesillo Abuelito 12oz Vacuum Pack 673130200000 Quesill...
Dairy·0 affected·Feb 17, 2021
CriticalFDA
El Abuelito Cheese, Inc.
Requeson/Ricotta, sold under the following brands and container sizes: El Abuelito Requeson Ricotta 12oz Clam Shell Container, UPC: 67313...
Food·0 affected·Feb 17, 2021
CriticalFDA
Adams.secret.co
Adam's Secret Extra Strength 3000, 840 mg, 10 count blister packs, Distributed by AS Inc., Made in USA, UPC 6 09728 43452 6.
Drugs·0 affected·Feb 15, 2021
CriticalFDA
Adams.secret.co
Adam's Secret Extra Strength 1500, 800 mg, 10 count blister packs, Distributed by KP Inc., Made in USA, UPC 6 09728 43462 5
Drugs·218 affected·Feb 15, 2021
CriticalFDA
Medtronic Vascular, Inc.
Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA).
Medical Implants·33,430 affected·Feb 12, 2021
CriticalFDA
Thompson Brands Llc
1. See's Candies brand chocolate 4.5 oz Sitting Bunny (SKU 600738) 2. See's Candies brand 1 oz Bunny (SKU 600741) 3. Gold Foil Balls (S...
Snacks & Candy·4 affected·Feb 11, 2021
CriticalFDA
Barbara's Orchard/delicae Gourmet
Thai Peanut Sauce, 12 fl. oz. (355ml), UPC code #643558406919
Food·85 affected·Feb 5, 2021
CriticalFDA
Harry And David Operations Inc
Harry & David brand Chocolate Cherries packaged in a clear 3 oz (85g) bag, UPC 7 80994 32341 4. This product is part of the Premium Deli...
Dairy·3,970 affected·Feb 5, 2021
CriticalFDA
Barbara's Orchard/delicae Gourmet
Spicy Red Curry Sauce, 12 fl. oz. (355ml), UPC code #643558406810
Food·52 affected·Feb 5, 2021
CriticalFDA
Barbara's Orchard/delicae Gourmet
Panang Curry Sauce, 12 fl. oz. (355ml), UPC code #643558406711
Food·62 affected·Feb 5, 2021
CriticalFDA
Medtronic Perfusion Systems
Medtronic Custom Pack Infant Tubingset Pixie Flow 0,8->1,5-1,8 1/B (PERFUSION M483203D 1/B). The Affinity Pixie Cardiotomy/Venous Reserv...
Respiratory Devices·14 affected·Feb 4, 2021
CriticalFDA
Medtronic Perfusion Systems
Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Ba...
Respiratory Devices·4 affected·Feb 4, 2021
CriticalFDA
Medtronic Perfusion Systems
Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B (PERFUSION M490817B 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) w...
Respiratory Devices·5 affected·Feb 4, 2021
CriticalFDA
Medtronic Perfusion Systems
Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurf...
Respiratory Devices·3 affected·Feb 4, 2021
CriticalFDA
Medtronic Perfusion Systems
Custom Perfusion System (CUSTOM PACK BB7W03R8 CCSM NEON). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is...
Respiratory Devices·7 affected·Feb 4, 2021
CriticalFDA
Medtronic Perfusion Systems
Medtronic Custom Perfusion Pack (CUSTOM PACK HY11B40R1 1/4 RESPIRATO). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance ...
Respiratory Devices·4 affected·Feb 4, 2021
CriticalFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viva family: Viva XT CRT-D, Viva XT Qua...
Medical Implants·238,393 affected·Feb 3, 2021
CriticalFDA
Ohio Hickory Harvest Brand Products, Inc.
Sprout's Vanilla Flavored Yogurt Covered Cranberries UPC 646670463778 12 Ounce Stand-Up Pouch Bag Ambient Storage
Dairy·409 affected·Feb 2, 2021
CriticalFDA
Apotex Corp.
Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injection 10 x 1 mL Single ...
Injectable Drugs·6,670 affected·Feb 2, 2021
CriticalFDA
Apotex Corp.
Enoxaparin Sodium Injection, USP 120 mg/ 0.8 mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injection 10 x 0.8 mL ...
Injectable Drugs·6,832 affected·Feb 2, 2021
CriticalFDA
Dole Fresh Vegetables Inc
Dole Endless Summer Salad Kit; 13 oz. bag UPC: 0-71430-01073-0 Contains Milk, Wheat Distributed by Dole Fresh Vegetables, Inc., M...
Dairy·2,828 affected·Jan 28, 2021
CriticalFDA
Bryant Ranch Prepack, Inc. Dba Brp Pharmaceuticals
Spironolactone Tablets, USP, 25 mg, packaged in: a) 30-count bottles (NDC 63629-1064-01), b) 60-count bottles (NDC 63629-1064-02), c) 90-...
Oral Drugs·35 affected·Jan 27, 2021
CriticalFDA
Meitheal Pharmaceuticals Inc
Cisatracurium Besylate Injection, USP, 10mg per 5mL (2 mg per mL), Single-Dose Vial (NDC 71288-712-05), packaged as 10 x 5 mL Single-Dose...
Injectable Drugs·34,860 affected·Jan 27, 2021
CriticalFDA
Maine Grains, Inc
Maine Grains Inc. brand Organic Yellow Peas sold between 10/17/2019 and 11/1/2020; product was packaged in 25lb bulk bags, 12 x 1lb cases...
Food·2,000 affected·Jan 26, 2021
CriticalFDA
Hong Thai Foods Corp
Golden Boy Custard Muffin Banana 220 grams/7.76 ounce packages
Food·19 affected·Jan 26, 2021
CriticalFDA
Frito-lay, Inc. Headquarters
RUFFLES "PARTY SIZE" ORIGINAL POTATO CHIPS 13 1/2 oz. UPC 028400034005 packaged in flexible bags
Snacks & Candy·50 affected·Jan 21, 2021
CriticalFDA
Calvin Scott & Company, Inc.
Benzonatate capsules, 100mg, repackaged in 30-count bottles, Distributed by Calvin Scott & Co., Inc, Albuq., NM. 87123, NDC 67877-0573-05
Oral Drugs·10 affected·Jan 15, 2021
CriticalFDA
Hamilton Co
HAMILTON HEATER SHAKER, 115 VAC/ 230 VAC, 750 VA, Power Consumption 41V/ 100W (max.), Relative Humidity 15% - 85% no condensation. REF 19...
Medical Devices·4,729 affected·Jan 15, 2021
CriticalFDA
Dole Fresh Vegetables Inc
Dole Chopped Kit Sesame Asian Salad & Topping Net Wt: 9.5 oz (269 g) Dressing Net: 2.5 FL oz (72 mL) Total Net Wt. 12.25 oz (347 g) ...
Produce·1,200 affected·Jan 5, 2021
CriticalFDA
Rhino Foods, Inc.
AF01886 NTFA No egg Ready-to-Eat Chocolate Chip Cookie Dough Dough- 20 lb. sold frozen
Bakery & Grains·3,280 affected·Dec 31, 2020
CriticalFDA
Divvies Llc
"Divvies Vegan and Nut Free Vanilla Cupcakes with Vanilla Frosting ***Net. Wt. 6 oz. "
Bakery & Grains·672 affected·Dec 29, 2020
CriticalFDA
Divvies Llc
"Divvies Vegan and Nut Free Vanilla Cupcakes with Chocolate Frosting ***Net. Wt. 6 oz.***"
Bakery & Grains·283 affected·Dec 29, 2020
CriticalFDA
Hill Pharma Inc
Pisiva Pea Protein 80% 20 kg (44 lbs) packaged in poly lined kraft paper bags.
Food·20,000 affected·Dec 28, 2020
CriticalFDA
B & I Overseas Trading Inc.
Herring in Oil with Italian Spices: Ingredients: Herring fillet pieces (fish) sunflower oil refined deodorized, edible salt, ground spic...
Seafood·400 affected·Dec 23, 2020
CriticalFDA
Fresenius Kabi Usa, Llc
Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials p...
Injectable Drugs·945,425 affected·Dec 23, 2020
CriticalFDA
Combat Medical Systems, Llc
Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenience kit. The Fresh Whole Blood Doner Set contains every...
Medical Devices·954 affected·Dec 23, 2020
CriticalFDA
Combat Medical Systems, Llc
Valkyrie LTOWB Collection (P/N 80-820, NSN 6515016862423). Blood collection convenience kit. The Valkyrie LTOWB Collection Set inclu...
Medical Devices·531 affected·Dec 23, 2020
CriticalFDA
Gh Foods Ca Llc
Spinach and Orzo Pasta Kit 2/5 lb. UPC: 20826766840209 Sold at Whole Foods Stores
Produce·3 affected·Dec 22, 2020