Year
2020 Product Recalls
3,943 product recalls issued in 2020 across CPSC, FDA, and USDA datasets.
3,943 recalls
High RiskFDA
B Braun Medical, Inc.
APEX Compounding System Control Panel Module, REF: 601237, Product Code AX1000 - Product Usage: intended for intravascular administration...
Medical Devices85 affectedNov 23, 2020
High RiskFDA
Covidien Llc
Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3. Intended for abdominal, gynecological, pediatric and ...
Surgical Devices5,316 affectedNov 23, 2020
High RiskFDA
Ge Healthcare, Llc
Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography ...
Cardiac Devices3 affectedNov 23, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma...
Diagnostic Devices731 affectedNov 23, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Naturalyte Liquid Acid concentrate bottles, Product Code 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices912 affectedNov 23, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-gl...
Diagnostic Devices397 affectedNov 23, 2020
High RiskFDA
B Braun Medical, Inc.
APEX Compounding System Control Panel Module, REF: 601224, Product Code AX1000 - Product Usage: intended for intravascular administration...
Medical Devices248 affectedNov 23, 2020
High RiskFDA
Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administ...
Medical Devices9,353 affectedNov 23, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Citrasate Liquid Acid concentrate bottles, Product Code 08-2251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices278 affectedNov 23, 2020
High RiskFDA
Roche Molecular Systems, Inc.
uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
Medical Devices27 affectedNov 23, 2020
High RiskFDA
Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the controlled administ...
Medical Devices140,006 affectedNov 23, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Naturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies S...
Medical Devices224 affectedNov 23, 2020
High RiskFDA
Baxter Healthcare Corporation
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usage: intended to be used for the controlled administration of...
Medical Devices112,463 affectedNov 23, 2020
High RiskFDA
Covidien Llc
Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended for abdominal, gynecological, pediatric and thora...
Surgical Devices3,255 affectedNov 23, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices3,083 affectedNov 23, 2020
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use
Medical Devices152 affectedNov 23, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Citrasate Liquid Acid concentrate drums, Product Code 13-2251 -CA - Product Usage: used in conjunction with Fresenius Renal Technologies ...
Medical Devices2 affectedNov 23, 2020
High RiskFDA
B Braun Medical, Inc.
APEX Compounding System Control Panel Module, REF: 601238, Product Code AX1000 - Product Usage: intended for intravascular administration...
Medical Devices16 affectedNov 23, 2020
CriticalFDA
Dole Fresh Vegetables Inc
Dole" Organic Romaine Hearts 3pk Organic Biologique) (UPC 0-71430-90061-1), Wild Harvest Organic Romaine Hearts, Net Wt 12 oz. (UPC 7...
Food2,203 affectedNov 21, 2020
RecallUSDA
Unknown
FSIS Issues Public Health Alert for Chicken and Beef Samosa Products Containing Pastry Ingredients That Have Been Recalled Due to Misbranding
Beef0 affectedNov 21, 2020
High RiskFDA
Riverside Natural Foods, Ltd.
Good & Gather Banana Chocolate Chip Date & Nut Bars, UPC 0 85239-04216 8. 5-1.6 oz (45g) Bars. Net Wt. 8oz (225g). DIST BY: Target Co...
Snacks & Candy508 affectedNov 20, 2020
High RiskFDA
Out Of The Kitchen, Llc
Chef Mitch Maier's Black Garlic Ketchup. Net Wt. 19 oz. (538g). UPC 8 60248-00254 5.
Food768 affectedNov 20, 2020
High RiskFDA
J F C International Inc
YAGUMO AMANATTO GIFT BOX 6P 6/19.01 OZ JAN Code: 49 03089 39050 4 Imported by JFC International Inc. Los Angeles, CA 90040
Food1,050 affectedNov 20, 2020
High RiskFDA
Out Of The Kitchen, Llc
Chef Mitch Maier's Black Garlic Sauce. Net Wt. 16 oz. (473g). UPC 8 60248-00253 8.
Food768 affectedNov 20, 2020
High RiskFDA
Out Of The Kitchen, Llc
Chef Mitch Maier's Black Garlic BBQ Sauce. Net Wt. 19 oz. (538g). UPC 8 60248-00251 4.
Food768 affectedNov 20, 2020
High RiskFDA
Complete Pharmacy And Medical Solutions, Llc.
HUMAN CHORIONIC GONADOTROPIN 1,250 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unprese...
Injectable Drugs2,400 affectedNov 20, 2020
RecallFDA
Novocol Pharmaceutical Of Canada, Inc.
Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor), packaged in cartons of 50 cartridges (1.7 mL each), Rx only, ...
Drugs15,398 affectedNov 20, 2020
High RiskFDA
Complete Pharmacy And Medical Solutions, Llc.
HUMAN CHORIONIC GONADOTROPIN 11,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpres...
Injectable Drugs1,182 affectedNov 20, 2020
High RiskFDA
Complete Pharmacy And Medical Solutions, Llc.
HUMAN CHORIONIC GONADOTROPIN 6,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unprese...
Injectable Drugs2,418 affectedNov 20, 2020
RecallFDA
Sca Pharmaceuticals
Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205
Injectable Drugs4,843 affectedNov 20, 2020
High RiskFDA
Complete Pharmacy And Medical Solutions, Llc.
HUMAN CHORIONIC GONADOTROPIN 5,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unprese...
Injectable Drugs1,144 affectedNov 20, 2020
High RiskFDA
Ortho-clinical Diagnostics, Inc.
enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product Usage: intended for use in the in vitro quantitat...
Diagnostic Devices40 affectedNov 20, 2020
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product Usage: These devices ...
Cardiac Devices58,438 affectedNov 20, 2020
High RiskFDA
Zimmer Biomet, Inc.
Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutter - Product Usage: The intended use of this instrument i...
Medical Devices4,713 affectedNov 20, 2020
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product Usage: intended to automate pre-analytical and post-analyti...
Medical Devices40 affectedNov 20, 2020
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794 - Product Usage: These devices are u...
Cardiac Devices0 affectedNov 20, 2020
High RiskFDA
Haag-streit Usa Inc
Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the operating microscopes ...
Surgical Devices3 affectedNov 20, 2020
RecallCPSC
Polaris Dealers Nationwide From March 2019 Through October 2020 For Between $18,600 And $32,300.
Polaris Recalls RZR Recreational Off-Highway Vehicles Due to Injury Hazard (Recall Alert)
Vehicles / Atvs18,400 affectedNov 19, 2020
High RiskFDA
Us Pharmaceuticals Inc.
CVS Health Hydrating Healing Ointment (Petrolatum 41%), Net Wt 3 OZ (85g), Distributed by CVS Pharmacy, Inc. One CVS Drive, Woonsocket, R...
Topical Drugs3,312 affectedNov 19, 2020
High RiskFDA
Areva Pharmaceuticals Inc
Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 2 mL Single-Dose Vial, Rx Only, Distributed by: Areva Pharmaceuticals, In...
Injectable Drugs3,287 affectedNov 19, 2020
High RiskFDA
Synthes (usa) Products Llc
DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.020S
Surgical Devices1,566 affectedNov 19, 2020
High RiskFDA
Steris Corporation
Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrument - Product Usage: intended to keep instruments moist during...
Medical Devices23,445 affectedNov 19, 2020
High RiskFDA
Synthes (usa) Products Llc
DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.019S
Surgical Devices1,231 affectedNov 19, 2020
High RiskFDA
Synthes (usa) Products Llc
DePuy Synthes 15.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.026S
Surgical Devices748 affectedNov 19, 2020
High RiskFDA
Synthes (usa) Products Llc
DePuy Synthes 13.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.022S
Surgical Devices1,447 affectedNov 19, 2020
High RiskFDA
Medtronic Neuromodulation
Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation ther...
Medical Implants12 affectedNov 19, 2020
CriticalFDA
Heartware, Inc.
Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101, f. Model 1...
Medical Implants19,562 affectedNov 19, 2020
High RiskFDA
Roche Molecular Systems, Inc.
The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and detection system for nucle...
Diagnostic Devices597 affectedNov 19, 2020