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
Depuy Orthopaedics, Inc.
Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.
Medical Devices·60 affected·Jan 8, 2021
High RiskFDA
Blue Stone Import Usa Inc
SAMYANG Buldak Hot Chicken Flavor Sauce, Hot Chili Sauce, Net Wt.: 200g (7.05oz)
Meat & Poultry·950 affected·Jan 7, 2021
High RiskFDA
Blue Stone Import Usa Inc
SAMYANG Buldak Hot Chicken Flavor Sauce - Carbonara, Hot Chili Sauce, Net Wt.: 200g (7.05oz)
Meat & Poultry·450 affected·Jan 7, 2021
RecallFDA
Bausch Health Companies, Inc.
Phytonadione Tablets 5mg, 30-count bottle, Rx Only, Manufactured For: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals No...
Oral Drugs·14,089 affected·Jan 7, 2021
High RiskFDA
American Health Packaging
Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton (10 capsules x 10 blister cards), Rx only, Distributed by...
Oral Drugs·1,948 affected·Jan 7, 2021
RecallFDA
Bausch Health Companies, Inc.
Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC Bridgewater,...
Oral Drugs·895 affected·Jan 7, 2021
High RiskFDA
Cardinal Health 200, Llc
Lab Coats SMS X-Large Blue, SKU 2203LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal ba...
Medical Devices·29,810,665 affected·Jan 7, 2021
High RiskFDA
Cardinal Health 200, Llc
Gown Isolation W/Ties Xl Blue, SKU 2201PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal...
Medical Devices·29,810,665 affected·Jan 7, 2021
High RiskFDA
Cardinal Health 200, Llc
Kendall Spill Kit, 6 Per Case, NonsterileI, BB6016K
Medical Devices·137,346 affected·Jan 7, 2021
High RiskFDA
Cardinal Health 200, Llc
Gown Isolation W/Ties Univ Blu, SKU 1200PG, 2200PG, 552200PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended...
Medical Devices·29,810,665 affected·Jan 7, 2021
High RiskFDA
Cardinal Health 200, Llc
ChemoPlus Drug Spill Kit-INSTI, SKU DP5016K
Medical Devices·137,346 affected·Jan 7, 2021
High RiskFDA
Cardinal Health 200, Llc
Lab Coats SMS 2X-Large White, SKU 2304LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal ...
Medical Devices·29,810,665 affected·Jan 7, 2021
High RiskFDA
Cardinal Health 200, Llc
Covidien ChemoPlus Chemo Spill Kit, Nonsterile, SKU DP5108K
Medical Devices·137,346 affected·Jan 7, 2021
High RiskFDA
Baxter Healthcare Corporation
The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numb...
Medical Devices·2,314 affected·Jan 7, 2021
High RiskFDA
Cardinal Health 200, Llc
ChemoPlus" Chemo Prep & Admin Kit, CT4025
Medical Devices·137,346 affected·Jan 7, 2021
High RiskFDA
Dlc Laboratories, Inc
Sulfur Ointment 10%, Pomada de Azufre, 2.6 OZ (73.7g) jar; Manufactured by/ Fabricado por: De La Cruz Products, A Division of DLC Laborat...
Topical Drugs·86,297 affected·Jan 6, 2021
High RiskFDA
Respironics California, Llc
PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 - Product Usage: The ventilator is intended to be used o...
Respiratory Devices·94 affected·Jan 6, 2021
High RiskFDA
Roche Diagnostics Operations, Inc.
9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and li...
Diagnostic Devices·1,214 affected·Jan 6, 2021
High RiskFDA
Weis Markets, Inc., Ice Cream Division
Klein s Cookies and Cream Bulk Packaged in a 3 gallon paper drum.
Dairy·665 affected·Jan 5, 2021
High RiskFDA
Weis Markets, Inc., Ice Cream Division
Klein s Vanilla Ice Cream. Packaged in a 3 gallon paper drum.
Dairy·502 affected·Jan 5, 2021
High RiskFDA
Weis Markets, Inc., Ice Cream Division
Weis Quality Cookies and Cream Ice Cream (48oz). Packaged in a squround paper container with a UPC of 041497-01253.
Dairy·10,869 affected·Jan 5, 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
RecallFDA
Biomeme, Inc.
Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infe...
Diagnostic Devices·147 affected·Jan 5, 2021
High RiskFDA
Ittella International, Llc
Tattooed Chef Plant-Based Sausage Breakfast Bowl Frozen 18-month shelf life Box Net wt. 40oz (1.13kg) UPC: 850015982569 Packed for:...
Frozen Food·12,213 affected·Jan 4, 2021
High RiskFDA
Nostrum Laboratories Inc
Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, In...
Oral Drugs·6,958 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX 25G 2.5MM, model no. NM-400U-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatme...
Medical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
KD-611L ELECTROSURGICAL KNIFE, model no. KD-611L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high...
Surgical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
K-202 GUIDE SHEATH KIT 2.0MM, model no. K-202 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respirato...
Respiratory Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0323 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal in...
Medical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
SD-230U-20 ELECTROSURGICAL SNARE, model no. SD-230U-20 - Product Usage: Used with endoscopes to electrosurgically resect tissue within th...
Surgical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
B7-2LA BALLOON CATHETER 13MM DIA 3.2, model no. B7-2LA - Product Usage: Used with endoscopes for injection of contrast medium or other me...
Surgical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX UP 2.8MMCH 23G 6MM, model no. NM-400L-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for th...
Medical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX UP 2.8MMCH 25G 6MM, model no. NM-400L-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for th...
Medical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX UP 2.8MMCH 21G 6MM, model no. NM-400L-0621 - Product Usage: Used with endoscopes to perform endoscopic injection for th...
Medical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
PR-V614M 2-LUMEN CANNULA, model no. PR-V614M - Product Usage: Used with endoscopes to inject contrast medium in the biliary or pancreatic...
Medical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
KD-620UR ELECTROSURGICAL SNARE, model no. KD-620UR - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using hi...
Surgical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX LOWER 25G 6MM, model no. NM-400U-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the tre...
Medical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX LOWER 23G 3MM, model no. NM-400U-0323 - Product Usage: Used with endoscopes to perform endoscopic injection for the tre...
Medical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
B-V233P-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V233P-A - Product Usage: Used with endoscopes to endoscopically remove stones such as...
Medical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX UP 2.8MMCH 25G 4MM, model no. NM-400L-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for th...
Medical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-401L-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the...
Medical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX UP 2.8MMCH 23G 6MM, model no. NM-400L-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for th...
Medical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
NA-401D-1321 ASPIRATION NEEDLE, model no. NA-401D-1321 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the ...
Respiratory Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
KD-655U ELECTROSURGICAL SNARE, model no. KD-655U - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high...
Surgical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
NA-201SX-4022-B ASPIRATION NEEDLE ViziShot 22G, model no. NA-201SX-4022-B - Product Usage: Used with ultrasound endoscopes for ultrasound...
Medical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX UP 2.8MMCH 21G 6MM, model no. NM-400L-0621 - Product Usage: Used with endoscopes to perform endoscopic injection for th...
Medical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610L-0523 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal in...
Medical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Ethicon, Inc.
Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated skin edges of wounds from surgi...
Surgical Devices·23,580 affected·Jan 4, 2021