Source

FDA Recalls

The U.S. Food and Drug Administration regulates drugs, medical devices, food, cosmetics, and tobacco products. Recall data here includes pharmaceutical adverse events and drug recalls.

68,659Total Recalls
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68,659 recalls
High RiskFDA
Roche Diagnostics Operations, Inc.
Triglycerides/Glycerol Blanked. In vitro test for the quantitative determination of triglycerides in human serum and plasma or Roche/H...
Medical Devices·6,255 affected·May 7, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
Creatinine Plus. Intended for use on Hitachi/MODULAR systems for the quantitative determination of the creatinine concentration in ser...
Medical Devices·6,255 affected·May 7, 2015
High RiskFDA
Atrium Medical Corporation
EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N
Medical Devices·390 affected·May 7, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
Lactate. Intended for use on COBAS INTEGRA 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems fo...
Medical Devices·6,255 affected·May 7, 2015
High RiskFDA
Atrium Medical Corporation
Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100
Medical Devices·1,170 affected·May 7, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
LDL-Cholesterol plus gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low...
Medical Devices·6,255 affected·May 7, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
Cholesterol Gen.2. The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in vitro diagnostic reagent system intended for us...
Diagnostic Devices·6,255 affected·May 7, 2015
High RiskFDA
Tortilleria Provincia
Tortilleria Provincia Refrigerate After Purchase Blue Corn Tortillas, Net Wt. 16 oz, 0 89780 10000 1 & 64 oz, 0 89780 10001 8, Tortilleri...
Food·96 affected·May 6, 2015
RecallFDA
Dr. Reddy's Laboratories, Inc.
Amlodipine besylate and Atorvastatin calcium tablets, 5mg/10mg, packaged in a)30-count bottle (NDC 43598-322-30), b) 90-count bottle (NDC...
Oral Drugs·0 affected·May 6, 2015
RecallFDA
Dr. Reddy's Laboratories, Inc.
Amlodipine besylate and Atorvastatin calcium tablets, 10mg/10mg, packaged in a)30-count bottle (NDC 43598-321-30), b) 90-count bottle (ND...
Oral Drugs·0 affected·May 6, 2015
RecallFDA
Dr. Reddy's Laboratories, Inc.
Amlodipine besylate and Atorvastatin calcium tablets, 10mg/40mg, 90-count bottle, Rx Only Manufactured by Dr. Reddy's Laboratories Limite...
Oral Drugs·0 affected·May 6, 2015
RecallFDA
Dr. Reddy's Laboratories, Inc.
Amlodipine besylate and Atorvastatin calcium tablets, 5mg/40mg packaged in a)30-count bottle (NDC 43598-316-30), b) 90-count bottle (NDC ...
Oral Drugs·0 affected·May 6, 2015
High RiskFDA
Smith & Nephew, Inc.
R3(TM) 28 MM I.D., 60 MM O.D. CONSTRAINED LINER, REF 71339160, QTY: (1), STERILE EO, Product Usage: The R3 Constrained liner Acetabu...
Medical Implants·40 affected·May 6, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc
The Rapidlab 1265 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in...
Medical Devices·2,713 affected·May 6, 2015
RecallFDA
Biocare Medical, Llc
D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In Vitro Diagnostic Use.: a mouse monoclon...
Diagnostic Devices·19 affected·May 6, 2015
High RiskFDA
Smith & Nephew, Inc.
R3(TM) 22 MM I.D., 58 MM O.D. CONSTRAINED LINER, REF 71339158, QTY: (1), STERILE EO. Product Usage: The R3 Constrained liner Acetabul...
Medical Implants·12 affected·May 6, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Siemens Material Number (SMN) 10386079, IVD. Fo...
Diagnostic Devices·17 affected·May 6, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
syngo Workflow SLR; The information system syngo Workflow SLR is a digital radiology information system (RIS) with integrated modules for...
Medical Devices·131 affected·May 6, 2015
High RiskFDA
Smith & Nephew, Inc.
R3(TM) 22 MM I.D., 56 MM O.D. CONSTRAINED LINER, REF 71339156, QTY: (1), STERILE EO. Product Usage: The R3 Constrained liner Acetabul...
Medical Implants·0 affected·May 6, 2015
High RiskFDA
Terumo Cardiovascular Systems Corp
Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary ...
Medical Devices·163 affected·May 6, 2015
High RiskFDA
Flying Food Group - Law
evolution FRESH brand Fresh Berries & Honey, Nonfat Greek Yogurt with Strawberries, Blueberries, Pure Honey, & Granola; NET WT 6.5 OZ/...
Dairy·2,568 affected·May 5, 2015
High RiskFDA
Edwards Lifesciences, Llc
Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery catheters for monitoring cardi...
Cardiac Devices·978 affected·May 5, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, MEVATRON M2/PRIMUS Mid-Energy, ARTISTE; intended...
Medical Devices·158 affected·May 5, 2015
High RiskFDA
Natural Creations Inc
Natural Creations Glucosamine MSM 90 capsules packaged in 250 cc white plastic containers with 52 bottles per case.
Food·644 affected·May 4, 2015
High RiskFDA
Creative Food Concepts
Coconut Water with Thai Lime, 12 bottles/case, 12 oz (355 mL)
Beverages·324 affected·May 4, 2015
CriticalFDA
Patel Grocery Corp
AMERICA'S BEST CORRIANDER POWDER, NET WT.: 1) 7 OZ, 2) 14 OZ. (400 GMS) and 3) 28 OZ, sealed in plastic bags, Packed by Patel Grocery 530...
Food·0 affected·May 4, 2015
RecallFDA
Ohm Laboratories, Inc.
Loratadine Orally Disintegrating Tablets USP, 10 mg, Antihistamine, Allergy Relief, 24 Hour, 30 Orally Disintegrating Tablets per blister...
Oral Drugs·2,592 affected·May 4, 2015
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and Articulated Arm Camera, 7700-103-001U Product ...
Medical Devices·72 affected·May 4, 2015
High RiskFDA
Smiths Medical Asd Inc
Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX ...
Medical Devices·6,000 affected·May 4, 2015
High RiskFDA
Ge Healthcare
GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).
Medical Devices·110 affected·May 4, 2015
CriticalFDA
Synovis Surgical Innovations, Inc.
Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, product code 1504026, 0.8x8cm, product cod...
Medical Devices·3,974 affected·May 2, 2015
High RiskFDA
Poco Dolce Confections, Inc.
Poco Dolce Bittersweet Chocolate: Ginger Tile, sea salt topped; 0.6 oz (17 grams) San Francisco CA. Ingredients: Bittersweet Chocola...
Dairy·34 affected·May 1, 2015
CriticalFDA
Sun Rich Fresh Foods Inc
Sun Rich Apple Slices with Caramel Dip, Parfait Cup, 6 x 6 oz.
Food·192 affected·May 1, 2015
CriticalFDA
Sun Rich Fresh Foods Inc
Fresh Cut Red Apple Slices 2 x 3 lbs; 4 x 3 lbs; USA 100x 2 oz.; 24 x 2 oz.; USA 3 lbs.
Food·28 affected·May 1, 2015
High RiskFDA
Poco Dolce Confections, Inc.
Poco Dolce Bittersweet Chocolate: Sesame Toffee Tile, sea salt topped; 0.6 oz (17 grams) San Francisco CA. Ingredients: Bittersweet ...
Dairy·34 affected·May 1, 2015
CriticalFDA
The Kroger Co
Kroger Raw #4 Macadamia Nut, Dist. by the Kroger Company Cincinnati, Ohio 2 04192 50867 6
Food·21 affected·May 1, 2015
High RiskFDA
Poco Dolce Confections, Inc.
Poco Dolce Bittersweet Chocolate: Burnt Caramel Tile, sea salt topped; 0.6 oz (17 grams) San Francisco CA. Ingredients: Bittersweet ...
Dairy·34 affected·May 1, 2015
CriticalFDA
Sun Rich Fresh Foods Inc
Sub Way Apple Slices, 2.4 oz. Bags
Food·11,129 affected·May 1, 2015
High RiskFDA
4 Him Food Group Llc
Salted Caramel Premium Puffed Corn, Cosmo Creations brand, Nitrogen filled, 3-layer laminate packaging, Net weight 14 oz., UPC 8 51710 00...
Food·33,240 affected·May 1, 2015
High RiskFDA
Poco Dolce Confections, Inc.
Poco Dolce Bittersweet Chocolate: Almond Tile, sea salt topped; 0.6 oz (17 grams) San Francisco CA. Ingredients: Bittersweet Chocola...
Dairy·34 affected·May 1, 2015
High RiskFDA
Poco Dolce Confections, Inc.
Poco Dolce Bittersweet Chocolate: Aztec Chili Tile, sea salt topped; 0.6 oz (17 grams) San Francisco CA. Ingredients: Bittersweet Ch...
Dairy·34 affected·May 1, 2015
CriticalFDA
Sun Rich Fresh Foods Inc
Sunshine Salad Kit, 10 lb.
Produce·110 affected·May 1, 2015
CriticalFDA
Top Taste, Inc
Fetting's Jumbo 2.5 oz Cinnamon Roll Dough 140, Approx. 120 count, Keep Frozen, NET WT 18.8 LB., UPC 0 75812 79140 0, Packaged in plasti...
Frozen Food·2,434 affected·May 1, 2015
CriticalFDA
John B. Sanfilippo & Son Inc.
Fisher Brand chopped walnuts, packaged in 10 ounce, polyethylene stand-up bag with zipper. The bag is blue with white lettering.
Seafood·5,885 affected·May 1, 2015
High RiskFDA
Poco Dolce Confections, Inc.
Poco Dolce Bittersweet Chocolate: Almond Coconut Tile, sea salt topped; 0.6 oz (17 grams) San Francisco CA. Ingredients: Bittersweet...
Dairy·34 affected·May 1, 2015
High RiskFDA
Integra Lifesciences Corp. D.b.a. Integra Pain Management
Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch. Plastic Hub, Metal Stylet, calibrations (10BX). Integ...
Medical Devices·123 affected·May 1, 2015
High RiskFDA
Biomet, Inc.
Unilateral external fixation ankle clamp Product Usage: Unilateral external fixation for use treatment of bone conditions amenable to...
Medical Devices·19 affected·May 1, 2015
High RiskFDA
Terumo Cardiovascular Systems Corporation
Base for Terumo Advanced Perfusion System 1, 220/240V The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on t...
Medical Devices·1,713 affected·May 1, 2015