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CriticalFDA
Ge Medical Systems Israel, Functional Imaging
GE Nuclear Medicine 600/800 series systems, specifically: a) 830, b) 830 / Dismount, c) 830 /, d) 830 / 5842894-20, e) 830 / Dismou...
Medical Devices·748 affected·Dec 19, 2022
CriticalFDA
Ge Medical Systems Israel, Functional Imaging
GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm, c) DISCOV NM/CT 8...
Medical Devices·86 affected·Dec 19, 2022
CriticalFDA
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 099...
Medical Devices·11,906 affected·Dec 19, 2022
CriticalFDA
Ge Medical Systems Israel, Functional Imaging
GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / Dismount, c) 850 3/8 inch NM Gantry, d) 860 / Dismount, e)...
Medical Devices·380 affected·Dec 19, 2022
High RiskFDA
Withings
Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen satu...
Cardiac Devices·38,886 affected·Dec 19, 2022
High RiskFDA
Klosterman Baking Company
Breads: Garlic product 8013 Clear Bag Rolls 140 1.5 oz. 3 Garlic product 8014 Clear Bag Breadsticks 110 1.5 oz. 23
Bakery & Grains·109,343 affected·Dec 18, 2022
High RiskFDA
Klosterman Baking Company
Breads: Pretzel product 8309 Clear Bag Buns 48 2.1 oz.
Bakery & Grains·109,343 affected·Dec 18, 2022
High RiskFDA
Klosterman Baking Company
Breads: Multigrain product 3481 Clear Bag Buns 12 62 g Multigrain product 8017 Clear Bag Loaf 1 28 oz.
Bakery & Grains·109,343 affected·Dec 18, 2022
High RiskFDA
Klosterman Baking Company
Breads: English Muffin product 9525 Clear Bag English Muffins 12 2 oz.
Bakery & Grains·109,343 affected·Dec 18, 2022
High RiskFDA
Klosterman Baking Company
Breads: Onion product 3655 Clear Film Buns 20 69 g
Bakery & Grains·109,343 affected·Dec 18, 2022
High RiskFDA
Klosterman Baking Company
Breads: Blueberry product 9531 Old World Bagels 6 3 oz. Blueberry product 9541 Old World Bagels 6 4 oz.
Bakery & Grains·109,343 affected·Dec 18, 2022
High RiskFDA
Klosterman Baking Company
Breads: Potato flour product 3555 Clear Bag Buns 12 80 g Potato flour product 3561 Clear Film Buns 20 92 g Potato flour product 6057 Cl...
Bakery & Grains·109,343 affected·Dec 18, 2022
High RiskFDA
Klosterman Baking Company
Breads: Ciabatta product 8000 Clear Bag Rolls 8 3.4 oz. Ciabatta product 8652 Clear Bag Rolls 6 5.5 oz.
Bakery & Grains·109,343 affected·Dec 18, 2022
High RiskFDA
Klosterman Baking Company
Breads: Wheat product 1305 Klosterman Foodservice UPC # 0005172100452 Loaf 1 28 oz. Wheat product 1306 Clear Bag Loaf 1 32 oz. Wheat p...
Bakery & Grains·109,343 affected·Dec 18, 2022
High RiskFDA
Klosterman Baking Company
Breads: Honey wheat product 1318 Clear Bag Loaf 1 32 oz. Honey wheat product 1410 Klosterman Retail UPC # 0005172100366 Loaf 1 12 oz. Ho...
Bakery & Grains·109,343 affected·Dec 18, 2022
High RiskFDA
Klosterman Baking Company
Breads: Yellow product 1444 Clear Bag Loaf 1 32 oz. Yellow product 1675 Clear Bag Loaf 1 24 oz. Yellow product 3139 Clear Bag Buns 12...
Bakery & Grains·109,343 affected·Dec 18, 2022
High RiskFDA
Klosterman Baking Company
Breads: Cuban product 8506 Clear Bag Loaf 1 16 oz.
Bakery & Grains·109,343 affected·Dec 18, 2022
High RiskFDA
Klosterman Baking Company
Breads: Sour Dough product 1728 Clear Bag Loaf 1 32 oz. Sour Dough product 1729 Clear Bag Loaf 1 32 oz. Sour Dough product 1979 Clear B...
Bakery & Grains·109,343 affected·Dec 18, 2022
High RiskFDA
Klosterman Baking Company
Breads: Croissant product 9013 Clear film Croissants 64 2.3 oz.
Bakery & Grains·109,343 affected·Dec 18, 2022
High RiskFDA
Klosterman Baking Company
Breads: Cornmeal product 3630 Clear Bag Buns 12 100 g
Bakery & Grains·109,343 affected·Dec 18, 2022
High RiskFDA
Klosterman Baking Company
Breads: Milk & Egg product 8098 Clear Bag Buns 8 2.5 oz. Milk & Egg product 8099 Clear Bag Buns 8 2.65 oz Milk & Egg product 8608 Clear...
Dairy·109,343 affected·Dec 18, 2022
High RiskFDA
Klosterman Baking Company
Breads: 100% whole wheat product 1415 Klosterman Retail UPC # 0005172100367 Loaf 1 12 oz. 100% whole wheat product 1448 Klosterman Retail...
Bakery & Grains·109,343 affected·Dec 18, 2022
High RiskFDA
Klosterman Baking Company
Breads: Focaccia product 8518 Clear Bag Loaf 1 56 oz.
Bakery & Grains·109,343 affected·Dec 18, 2022
High RiskFDA
Klosterman Baking Company
Breads: Frenchbread product 8510 Clear Bag Loaf 1 16 oz. Frenchbread product 8550 Clear Bag Loaf 1 16 oz. Frenchbread product 8551 Clea...
Bakery & Grains·109,343 affected·Dec 18, 2022
High RiskFDA
Klosterman Baking Company
Breads: White product 1003 Clear Bag Loaf 1 24 oz. White product 1005 Clear Bag Loaf 1 24 oz. White product 1015 Clear Bag Loaf 1 24...
Bakery & Grains·109,343 affected·Dec 18, 2022
High RiskFDA
Klosterman Baking Company
Breads: Everything product 9545 Old World Bagels 6 4 oz.
Bakery & Grains·109,343 affected·Dec 18, 2022
High RiskFDA
Klosterman Baking Company
Breads: Raisin product 1645 Clear Bag Loaf 1 24 oz. Raisin product 1648 Clear Bag Loaf 1 24 oz. Raisin product 9532 Old World Bagels...
Bakery & Grains·109,343 affected·Dec 18, 2022
High RiskFDA
Woodland Foods Llc
D'allesandro Hickory Smoked Almonds, 5lbs, UPC 00687080258684; Woodland Foods Hickory Smoked Almonds, 25lbs, UPC 00687080258691
Food·2,535 affected·Dec 16, 2022
CriticalFDA
Ventura Foods Llc
Culvers Tartar Sauce 2 oz. plastic cups
Food·126 affected·Dec 16, 2022
High RiskFDA
Aurolife Pharma, Llc
Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-01...
Oral Drugs·7,344 affected·Dec 16, 2022
High RiskFDA
Hikma Pharmaceuticals Usa Inc.
Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, Rx Only, Mfd. by: THYMOORGAN PHARMAZIE GmbH, Germany, Dist...
Injectable Drugs·13,760 affected·Dec 16, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor
Medical Devices·550 affected·Dec 16, 2022
High RiskFDA
Access Vascular, Inc
HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002
Medical Devices·0 affected·Dec 16, 2022
High RiskFDA
Carbon Medical Technologies, Inc.
Mammotome MammoStar Biopsy Site Identified, REF STAR1401
Medical Devices·550 affected·Dec 16, 2022
High RiskFDA
Novasignal Corp.
NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of NovaBot Automated Headset (AKA: NeuralBot, Model: NA-RBT1) and L...
Medical Devices·4 affected·Dec 16, 2022
High RiskFDA
Access Vascular, Inc
HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002
Medical Devices·1,789 affected·Dec 16, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 ...
Medical Devices·609 affected·Dec 16, 2022
High RiskFDA
Pietrzyk Foods
PIETRZYK PIEROGI THE HOLY GOUDA PIEROGI, NET WT. 26.5oz (742g), 1 DOZEN UPC 850014236069
Food·39 affected·Dec 15, 2022
High RiskFDA
Frenda Corporation
Easy Clean Alcohol Mult Surface Disinfecting Cleaner 75% Ethyl Alcohol, 32 FL. OZ. (946 mL.), Manufactured by: Frenda Corporation Trujili...
Drugs·8,475 affected·Dec 15, 2022
High RiskFDA
Frenda Corporation
Global Care 70% Alcohol Ethyl Rubbing Alcohol, packaged in a) 32 FL OZ (946 mL) UPC 8 70373 01323 1; b) 16 FL OZ (473 mL) UPC 8 70373 013...
Drugs·12,130 affected·Dec 15, 2022
High RiskFDA
Frenda Corporation
Easy Clean 70% Isopropyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8 91857 00048 6; b) 16 fl. oz. (473 mL) UPC 8 91857 00047 9, ...
Drugs·65,376 affected·Dec 15, 2022
High RiskFDA
Frenda Corporation
Easy Clean Antiseptic Hand Sanitizer Solution 65% with Glycerine, 1 Gallon (128 Fl. oz.), Manufactured by: Frenda Corporation Trujillo A...
Drugs·144 affected·Dec 15, 2022
High RiskFDA
Frenda Corporation
Global Care Antibacterial Hand Sanitizer Alcohol Etilico 70% Original, 1 Gallon (128 FL OZ) 3785.41 mL, Dist. by Target Price, Inc. Catan...
Drugs·124 affected·Dec 15, 2022
High RiskFDA
Frenda Corporation
Easy Clean Isopropyl Alcohol 99%, 1 Gallon (128 fl. oz.), Manufactured by: Frenda Corporation Trujillo Alto, PR 00976, UPC 8 91857 00054 7
Drugs·164 affected·Dec 15, 2022
High RiskFDA
Frenda Corporation
Easy Clean 75% Ethyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8 91857 00045 5; b) 16 fl. oz. (473 mL) UPC 8 91857 00055 4; c) R...
Drugs·44,140 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick Medical Distribution.
Medical Devices·250 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology.
Medical Devices·112,675 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Technology.
Medical Devices·76,260 affected·Dec 15, 2022