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High RiskFDA
Hom'ade Foods
Mary B's Southern Made, 12 Biscuits, NET WT. 26.4 oz (1LB 10.4OZ) 748g; Mary B's Southern Made, 20 Biscuits, Value Pack, NET WT. 44 oz (2...
Food·562,302 affected·Jan 8, 2018
High RiskFDA
Hom'ade Foods
Mary B's Made with Whole Grain, 220CT, Bulk Biscuits
Food·562,302 affected·Jan 8, 2018
High RiskFDA
Innovasis, Inc
Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization an...
Medical Devices·1,010 affected·Jan 8, 2018
High RiskFDA
Mom's Delicious Kitchen Llc
Kvas, a fermented non-alcoholic drink, packaged in a gallon plastic jugs The label is read in parts: "***Mom's Kvas***1 Gallon***Ingre...
Beverages·0 affected·Jan 5, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392 AXIOM Artis is a family of dedicated angiography syst...
Diagnostic Devices·22 affected·Jan 5, 2018
High RiskFDA
Biomerieux, Inc.
BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automa...
Diagnostic Devices·1,866 affected·Jan 4, 2018
High RiskFDA
Toshiba American Medical Systems Inc
Diagnostic Ultrasound System, Aplio I-series. Labeled as i700, i800, i900 The power supply unit may be damaged and may fail to start ...
Diagnostic Devices·162 affected·Jan 4, 2018
High RiskFDA
Avkare Inc.
Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pulaski, TN 38478, NDC 50268-51...
Oral Drugs·237 affected·Jan 3, 2018
High RiskFDA
Medtronic Perfusion Systems
Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.
Surgical Devices·2,914 affected·Jan 3, 2018
High RiskFDA
Getinge Us Sales Llc
HEMASHIELD Knitted Double Velour Cardiovascular Fabric
Medical Devices·1 affected·Jan 3, 2018
High RiskFDA
Philips Electronics North America Corporation
Intellivue iX Information Center Software - All PIIC iX Surveillance stations including: 866023 IntelliVue Info Center iX A.0 866117 PI...
Medical Devices·20,357 affected·Jan 3, 2018
High RiskFDA
Esaote S.p.a.
MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, CA541, EC1123, EC123, IH 618, IOT332, IOT342, L 415, LA332E,...
Medical Devices·5 affected·Jan 3, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi BR-MA (CA15-3)
Medical Devices·0 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE ¿ /IMMULITE 1000 ¿ Gastrin
Medical Devices·0 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE ¿ /IMMULITE ¿ 1000 BR-MA (CA15-3)
Medical Devices·0 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE ¿ /IMMULITE ¿ 1000 OM-MA (CA125)
Medical Devices·0 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur¿ DHEA-SO4
Medical Devices·0 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Gastrin
Medical Devices·0 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Anti HBc
Medical Devices·0 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension¿ Free Thyroxine (FT4L) Flex¿ reagent cartridge
Diagnostic Devices·0 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista¿ Mass Creatine Kinase (MMB) Flex¿ reagent cartridge
Diagnostic Devices·0 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur¿ HBc IgM
Medical Devices·6 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE ¿ /IMMULITE ¿ 1000 CEA
Medical Devices·0 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi CEA
Medical Devices·0 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension¿ Sirolimus (SIRO) Flex¿ reagent cartridge
Diagnostic Devices·0 affected·Jan 2, 2018
High RiskFDA
Roche Diagnostics Corporation
Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminophen150 test
Diagnostic Devices·35,111 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista¿ Thyroid Stimulating Hormone (TSH) Flex¿ reagent cartridge
Diagnostic Devices·0 affected·Jan 2, 2018
High RiskFDA
Stryker Sustainability Solutions
Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134301, Sterile, Rx. The R...
Cardiac Devices·170 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Folic Acid
Medical Devices·0 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur¿ Cyclosporine
Medical Devices·0 affected·Jan 2, 2018
High RiskFDA
Blommer Chocolate Company Of California, Llc
Blommer Chocolate Company ERNIES (chocolate candy centers with candy shell) Net Wt. 25 lbs. Ingredients: Sugar, cocoa, hydrogenated ...
Dairy·20,000 affected·Dec 31, 2017
High RiskFDA
Lovebiotics, Llc
The Coconut Cult Coconut Cream Probiotic Coconut Yogurt NET WT. 8 OZ, 16 OZ, 32 OZ UPC 611138765282, 611138765275, 611138765268
Dairy·2,977 affected·Dec 29, 2017
High RiskFDA
Lovebiotics, Llc
The Coconut Cult Mango Cream Probiotic Coconut Yogurt NET WT. 8 OZ, 16 OZ, 32 OZ UPC 611138765244, 611138765251, 611138765237
Dairy·2,977 affected·Dec 29, 2017
High RiskFDA
Toshiba American Medical Systems Inc
INFX-8000C Fluoroscopic X-Ray Systems
Medical Devices·19 affected·Dec 29, 2017
High RiskFDA
Toshiba American Medical Systems Inc
INFX-8000F Fluoroscopic X-Ray Systems
Medical Devices·17 affected·Dec 29, 2017
High RiskFDA
Toshiba American Medical Systems Inc
INFX-8000H Fluoroscopic X-Ray Systems
Medical Devices·2 affected·Dec 29, 2017
High RiskFDA
Sister Schubert's Rolls Division Of T.marzetti Company
Southern Style Frozen Biscuits sold under the following brand names: Food Club, Food Lion, Laura Lynn, Lowes Foods, Marshalls, Morning Fr...
Frozen Food·101,126 affected·Dec 28, 2017
High RiskFDA
Dlc Laboratories, Inc
Earth's Care Eczema Lotion (2% Colloidal Oatmeal) Skin Protectant with Aloe and Almond Oil, 8 fl. oz. (237 mL) HPDE bottle, Distributed b...
Drugs·4,081 affected·Dec 28, 2017
High RiskFDA
Southwest Technologies Inc
HYPOTHERMIA CAP Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), CAP610 (b) Elasto-Gel(TM), CAP610LV (c)...
Medical Devices·15,666 affected·Dec 28, 2017
High RiskFDA
Implantcast Gmbh
2M insert 15degree for MUTARS RS cup and LUMiC TiN orthopedic hip implant acetabular component. Size 38/39 mm REF number 02423839 Si...
Medical Implants·304 affected·Dec 28, 2017
High RiskFDA
Bard Access Systems Inc.
PowerPICC Provena Catheters, as 3 Fr. Single lumen and 4 Fr. Dual Lumen. Packaged in a poly tray with Tyvek lid within a header bag conf...
Surgical Devices·53,699 affected·Dec 28, 2017
High RiskFDA
Epimed International
NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile
Medical Devices·140 affected·Dec 28, 2017
High RiskFDA
Schmidt Baking Co., Inc.
BUTTER MILK ( Under the following Trade Names - SUNBEAM 2PK, SUNBEAM )
Dairy·14,910 affected·Dec 27, 2017
High RiskFDA
Schmidt Baking Co., Inc.
POTATO SLAMMERS ( Under the following Trade Names - SCHMIDT, WHOLE FOODS, HP, WEIS, PLAIN BAG 12 and 24 PK )
Food·6,072 affected·Dec 27, 2017
High RiskFDA
Schmidt Baking Co., Inc.
WHITE WHEAT S/T DINNERS ( Under the following Trade Names - ULTRA GRAIN, O/T )
Food·25,146 affected·Dec 27, 2017
High RiskFDA
Schmidt Baking Co., Inc.
WHITE WHEAT HAMS( Under the following Trade Names - OT, WEIS, ULTRA GRAIN )
Food·71,664 affected·Dec 27, 2017
High RiskFDA
Schmidt Baking Co., Inc.
WHITE WHEAT R/T ( Under the following Trade Names - O/T 2PK, O/T, WEIS, ULTRA GRAIN )
Food·23,070 affected·Dec 27, 2017
High RiskFDA
Schmidt Baking Co., Inc.
POTATO HAMS( Under the following Trade Names - OT 16 CT, OT)
Food·44,868 affected·Dec 27, 2017