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
Sofradim Production
Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M The device is made out of a macroporous three-dimensional monofilament poly...
Medical Devices·703 affected·Feb 23, 2018
High RiskFDA
Conmed Corporation
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog Number 2602 Indicated for use in external pac...
Cardiac Devices·18,720 affected·Feb 23, 2018
High RiskFDA
Deerfield Imaging, Inc.
IMRIS T2X Table, Part Numbers: (a) 108000-000 (b) 108000-600 (c) 109682-000 (d) 109682-600
Medical Devices·14 affected·Feb 23, 2018
High RiskFDA
Conmed Corporation
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H Indicated for use in external p...
Cardiac Devices·18,720 affected·Feb 23, 2018
High RiskFDA
Ge Healthcare
GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 2049588-008 Product Usage: Centricity PACS-IW by GE Healthcare...
Medical Devices·569 affected·Feb 23, 2018
High RiskFDA
Conmed Corporation
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, ZOLL¿ Connector, REF/Catalog Number 2602Z Indicated for use in external pacing, defibr...
Cardiac Devices·18,720 affected·Feb 23, 2018
RecallFDA
Sca Pharmaceuticals, Llc.
labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pharmaceuticals, Windsor, CT 06095 --- NDC 70004-0700...
Injectable Drugs·480 affected·Feb 22, 2018
High RiskFDA
Roche Diagnostics Corporation
cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 3313522692 The Roche Diagnostics Omni S Analyzer is a fully automa...
Diabetes Devices·1,026 affected·Feb 22, 2018
High RiskFDA
Roche Diagnostics Corporation
cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer is a fully automa...
Diabetes Devices·1,026 affected·Feb 22, 2018
High RiskFDA
Roche Diagnostics Corporation
cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154001 and 3337154692 The Roche Diagnostics Omni S Analyzer is a fully autom...
Diabetes Devices·1,026 affected·Feb 22, 2018
High RiskFDA
Munk Pack Inc
Munk Pack PROTEIN COOKIE PEANUT BUTTER CHOCLATE CHIP NET WT 2.96oz (84g); UPC: 853787005351
Dairy·1,774 affected·Feb 21, 2018
CriticalFDA
Sunneen Health Foods, Llc
Whole Foods Vegan Buffalo Chicken Bites; Net Wt. 9 oz; Expiration Date: 2/27/2018; UPC: 636910500059
Meat & Poultry·60 affected·Feb 21, 2018
High RiskFDA
Munk Pack Inc
Munk Pack PROTEIN COOKIE DOUBLE DARK CHOCOLATE NET WT 2.96oz (84g); UPC: 853787005368
Bakery & Grains·1,774 affected·Feb 21, 2018
CriticalFDA
La Pasta, Inc.
HEINEN'S Potato Gnocchi * Preservative Free * 9 oz. (225 g) in clear film plastic trays
Food·208 affected·Feb 21, 2018
High RiskFDA
Renaissance Lakewood, Llc
Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), package in 100 mL bags, Rx only, Manufacture...
Injectable Drugs·1,784 affected·Feb 21, 2018
RecallFDA
Akorn, Inc.
Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC...
Ophthalmic Drugs·31,812 affected·Feb 21, 2018
High RiskFDA
Hycor Biomedical Inc
AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor IgM ELISA is intended to be utilized as either ...
Diagnostic Devices·207 affected·Feb 21, 2018
RecallFDA
Coopervision Inc.
clariti 1 day (-1.25) 90 pack, UV Blocking, 90 silicone hydrogel, daily disposable contact lenses The Clariti 1 Day (somofilcon A) So...
Medical Devices·32 affected·Feb 21, 2018
High RiskFDA
Datascope Corporation
Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide co...
Cardiac Devices·655 affected·Feb 21, 2018
High RiskFDA
Allen Medical Systems
F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table accessory system used to allow prone positioning on OR table...
Surgical Devices·83 affected·Feb 21, 2018
High RiskFDA
Datascope Corporation
Intra-Aortic Balloon Catheter Mega 7.5FR 40cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide co...
Cardiac Devices·2,714 affected·Feb 21, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 64 with 4.1.7 XX026 software version model number 728231 Product Usage: Computed Tomography X-ray systems intended to prod...
Medical Devices·291 affected·Feb 21, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/500 tests)
Diagnostic Devices·10,310,443 affected·Feb 21, 2018
High RiskFDA
Datascope Corporation
Intra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counte...
Cardiac Devices·12,744 affected·Feb 21, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic an...
Medical Devices·14 affected·Feb 21, 2018
High RiskFDA
Margalaxy Llc
Cosmic Crunch Granola, packaged in paper bag, net wt 10 oz. The product is labeled in parts: "***COSMIC CRUNCH superfood granola***1...
Bakery & Grains·20 affected·Feb 20, 2018
CriticalFDA
Lotte International America Corp.
Lotte Kancho Choco-Biscuit; Sold as Lotte Kancho - 42 g -1.48 oz. UPC CODE: 8801062 144815; Lotte Kancho Cup - 95 g cup - UPC CODE: ...
Dairy·4,657 affected·Feb 20, 2018
RecallFDA
Bob's Red Mill Natural Foods, Inc.
Buttermilk Pancake and Waffle Mix, Item number: 6170B25, packaged in 25 lbs. bulk kraft bag. The label is read in parts: "***BUTTERMIL...
Dairy·786 affected·Feb 20, 2018
CriticalFDA
Market Of Choice Inc
Sezam Kale Salad ingredient kits, net wt. 6.43 pound. Ingredients are packaged individually and then placed in one large bag. The ingre...
Produce·16 affected·Feb 20, 2018
High RiskFDA
Hospira Inc. A Pfizer Company
Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial, Rx only, labeled as a) Hospira, Inc., Lake Forest,...
Injectable Drugs·137,975 affected·Feb 20, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173 Syngo.Plaza is a Picture Archiving and Communication System (PA...
Medical Devices·92 affected·Feb 20, 2018
High RiskFDA
Cardinal Health 200, Llc
Presource PBDS, Kit, Common. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chl...
Surgical Devices·8,928 affected·Feb 20, 2018
High RiskFDA
Cardinal Health 200, Llc
Presource PBDS, Kit, No Spiro Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a pack...
Diabetes Devices·8,928 affected·Feb 20, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.plaza software Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report,...
Medical Devices·92 affected·Feb 20, 2018
High RiskFDA
Deerfield Imaging, Inc.
IMRIS T2X Table, Part Number 109682-600
Medical Devices·16 affected·Feb 20, 2018
High RiskFDA
Cardinal Health 200, Llc
Presource PBDS, Kit, Common Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet...
Diabetes Devices·8,928 affected·Feb 20, 2018
High RiskFDA
Ventura Foods, Llc
Gordon Choice Asian Sesame Ginger Dressing, Net Contents/Contenido Neto 128 FL OZ; For Distribution Exclusively By Gordon Food Service Wy...
Food·144 affected·Feb 19, 2018
High RiskFDA
Kalchem International, Inc.
Vardenafil HCl, USP (trihydrate), 500 GM Part # 330-05, Rx only, For Manufacturing, Repackaging and Processing for Rx and Research Only, ...
Drugs·500 affected·Feb 19, 2018
CriticalFDA
Zimmer Biomet, Inc.
EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of lon...
Medical Implants·4,879 affected·Feb 19, 2018
CriticalFDA
Zimmer Biomet, Inc.
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal...
Medical Implants·4,879 affected·Feb 19, 2018
High RiskFDA
M & P Food Productions, Ltd.
M&P Food Productions brand Vareniki Cabbage, Net WT 14 oz. (396g), Keep Frozen, UPC: 7 07163 02619 8
Frozen Food·0 affected·Feb 16, 2018
High RiskFDA
M & P Food Productions, Ltd.
M&P Food Productions brand Vareniki, Potato and Mushroom, Net Wt. 14 oz. (396 g), Keep Frozen, UPC: 7 07163 02617 4
Frozen Food·0 affected·Feb 16, 2018
High RiskFDA
Double-cola Co.-usa Dba The Double Cola Company
Cherry SKI LEMON ORANGE AUTHENTIC CITRUS SODA 12 oz can CONTAINS: CARBONATED WATER, HIGH FRUCTOSE CORN SYRUP, LEMON JUICE CONCENTRATE, OR...
Beverages·200 affected·Feb 16, 2018
High RiskFDA
M & P Food Productions, Ltd.
M&P Food Productions brand Vareniki Potato and Onion, Net Wt. 14 oz. (396 g), Keep Frozen, UPC: 7 0 7163 02616 7
Produce·0 affected·Feb 16, 2018
High RiskFDA
M & P Food Productions, Ltd.
M&P Food Productions brand Hand Made Russian Style Blintzes, (6 pieces): Cheese, Net Wt. 14 oz. (396 g); UPC Codes: 7 07163 30325 1, Keep...
Dairy·0 affected·Feb 16, 2018
High RiskFDA
M & P Food Productions, Ltd.
M&P Food Productions brand Vareniki Sour Cherry, Net Wt. 14oz (396g), Keep Frozen, UPC: 7 07163 02615 0
Frozen Food·0 affected·Feb 16, 2018
High RiskFDA
M & P Food Productions, Ltd.
M&P Food Productions brand Hand Made Russian Style Blintzes, (6 pieces): Cheese and Cherry, Net Wt. 14 oz. (396g), UPC Codes: 7 07163 303...
Dairy·0 affected·Feb 16, 2018
RecallFDA
Bob's Red Mill Natural Foods, Inc.
Organic Creamy Wheat Hot Cereal, Item number 6097C244, Pack size: 24 oz bag, 4 bags in a case. UPC: 3997800992
Bakery & Grains·469 affected·Feb 16, 2018