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Vehicle Safety

Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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Browse Device Recalls

3,664 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,664 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 3,664 FDA device recalls, Class I.

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DateProductReasonClassFirm
May 20, 2014 LAPAROTOMY PACK - (I) SURGICAL BLADE #10 S/STEEL ( I) UTILITY BOWL 32oz ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Breast Pack MRT, code 900-2658, contains: ( 1) BULB SYRINGE 60cc (2) GOWN S... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 C - BIRTH PACK II {2) CUSTOMED CONTENT: (1) GOWN SURGEON REINFORCED XLGE... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 SHOULDER ARTHROSCOPY PACK CONTENTS: (1) SUTURE BAG FLORAL (1) UTILITY ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 ANGIOGRAPHY PACK - (1) LINE H.P. 1200 PSI 48" M/F (1) ANG. FEMORAL DRAPE W... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Customed Major Laparotomy Pack , convenience pack include multiple components... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Bandeja para Debridacion, code 900-2702, contains: (1) FORCEP ADSON TISS (... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 PERY GYN PACK- CUSTOMED- (1) DRAPE ABDOMINAL WITH TAPE UF (1) TOWEL ABSO... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 CENTRAL LINE FULL BODY DRAPE CUSTOMED CONTENTS: (1) WRAPPER 30" X 30" ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Face Pack FJG, code 900-3116, contains: (2) GOWN LARGE STANDARD SMS AAMIIII ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 LAPAROTOMY PACK - CUSTOMED- (1) BAG SUTURE FLORAL (2) TOWEL ABSORBENT 15" ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 TRAATEK NEURO PACK (4)TOWEL ABSORBENT 15" X 20" LIF ( 1) MAYO STAND COVER... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 LITHOTOMY PACK CONTENTS: (2) TOWELS ABSORBENT 15" X 20" (2) LEGGINGS W... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 FEMORAL ANGIOGRAPHY PACK - (1) TABLE COVER REINFORCED 50" X 90" UF (1) GOW... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 LAPAROTOMY PACK Ill (4) CUSTOMED CONTENT: (4) TOWEL ABSORBENT 15" X 20" ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Tummy Tuck and Liposuction Pack, code 900-2661, contains: ( 1) DRAPE % ECONO... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 O.R. TOWELS- CUSTOMED- (6) TOWELS CLOTH HUCK BLUE ( I) WRAPPER 20" X 20 ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 0.B. PACK - - (1) TABLE COVER 44" x 90" (1) UNDERBUTTOCK DRAPE WITH POUCH ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 OPHTALMIC PACK- (3) ABSORBENT TOWELS 15" X 20" LIF (1) MAYO STAND COVER REI... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 ORTHOPEDIC PACK I (2) CUSTOMED, 900-2503, contains: (2) TOWELS ABSORBENT 15"... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 16, 2014 Manual Resuscitator Bag Series: AF1000, AF2000, AF3000, AF4000, AF5000, BT200... The pop-off valve in the defective devices remain open and a squeeze of the bag may not generate ... Class I Ventlab LLC
May 5, 2014 ADVOCATE Redi-Code+ BMB-BA006A Blood Glucose test strips Product Usage: T... "Advocate Redi-Code + BMB-BA006A Blood Glucose test strips" are inappropriately labeled and marke... Class I DIABETIC SUPPLY OF SUNCOAST, INC.
Apr 29, 2014 Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 ... Convatec Inc. is recalling Flexi-seal FMS Control Kit since it does not have a 510K. In addition,... Class I Convatec Inc.
Apr 23, 2014 Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits... CareFusion is recalling the Alaris Pump model 8100 version 9.1.18 because it may have a software ... Class I CareFusion 303, Inc.
Apr 22, 2014 HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31. Anes... Ventilation and alarms of a HAMILTON-G5 ventilator can be suppressed unintentionally after the ac... Class I Hamilton Medical, Inc.
Apr 16, 2014 DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies an... DePuy Synthes is initiating a recall of certain lots of the Craniomaxillofacial Distraction Syste... Class I Synthes, Inc.
Apr 16, 2014 Alere INRatio2 PT/INR Professional Test Strips, Model Number: 99008G2. The Al... Test Strips may report an inaccurately low INR result. Several patients had a therapeutic or nea... Class I Alere San Diego, Inc.
Apr 15, 2014 Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal. CPAP... The Infant Nasal CPAP Prong has the potential to detach from the Nasal Tubing and therapy is like... Class I Fisher & Paykel Healthcare, Ltd.
Apr 10, 2014 Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The c... One lot of 3.0mm sized Connectors, Product Reorder No. 10035-05PS, Lot No. 2553426 were placed in... Class I Smiths Medical ASD, Inc.
Apr 10, 2014 Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle Part Number: 08-... Naturalyte Liquid Bicarbonate maybe contaminated Class I Fresenius Medical Care Holdings, Inc.
Apr 2, 2014 ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculat... 1. ABACUS v3.1 may calculate quantities of electrolytes that are double the expected values durin... Class I Baxter Corporation Englewood
Apr 1, 2014 Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculatur... Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delive... Class I Micro Therapeutics Inc, Dba Ev3 Neurovascular
Apr 1, 2014 Pipeline Embolization Device (PED). Used endovascular treatment of adults wi... Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delive... Class I Micro Therapeutics Inc, Dba Ev3 Neurovascular
Mar 25, 2014 IPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the managem... Potential for microbial contamination of the product. Class I Wellspring Pharmaceutical Corporation
Mar 21, 2014 Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump.... Potential mechanical failure of the fan assembly associated with the power supply. A fan assembly... Class I Maquet Datascope Corp - Cardiac Assist Division
Mar 10, 2014 SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installe... The System may go into a controlled failed state if a series of parameters on the user interface ... Class I Del Mar Reynolds Medical, Ltd.
Mar 5, 2014 Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Par... The potentiometers (knobs) for setting the ventilation parameters may have contact interrupted an... Class I Draeger Medical Systems, Inc.
Mar 4, 2014 HeartMate II System Controller Product Usage: HeartMate II is a mechanica... Discovery of serious injuries and deaths associated with the process of changing from a primary S... Class I Thoratec Corporation
Mar 4, 2014 HeartMate II LVAD Pump and Pock Controller Kit; Product Usage: HeartMat... Discovery of serious injuries and deaths associated with the process of changing from a primary S... Class I Thoratec Corporation
Mar 4, 2014 Heart Mate II Pocket Controllers removed from packaging Product Usage: ... Discovery of serious injuries and deaths associated with the process of changing from a primary S... Class I Thoratec Corporation
Mar 4, 2014 HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) w... Discovery of serious injuries and deaths associated with the process of changing from a primary S... Class I Thoratec Corporation
Feb 19, 2014 FreeStyle Blood Glucose Monitors System. For in vitro diagnostic use only. S... Abbott Diabetes Care has identified through internal testing and investigation that all non-appli... Class I Abbott Diabetes Care, Inc.
Feb 19, 2014 FreeStyle Flash Blood Glucose Monitors System. Meter made in China; Dis... Abbott Diabetes Care has identified through internal testing and investigation that all non-appli... Class I Abbott Diabetes Care, Inc.
Feb 18, 2014 GemStar Docking Station, used with GemStar infusion pump, in combination with... There are two situations that may occur when using the GemStar Docking Station, List Number 13075... Class I Hospira Inc.
Feb 11, 2014 Trilogy Ventilators The Respironics Trilogy 100 system provides continuous o... Internal testing revealed a potentially defective component on the power management board that co... Class I Phillips Respironics, Inc.
Feb 7, 2014 SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product U... Baxter Healthcare Corporation has issued an Urgent Device Correction for the SIGMA SPECTRUM Volum... Class I Baxter Healthcare Corp.
Feb 7, 2014 Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care... The battery capacity of the optional PS500 Power Supply Unit of the Infinity ACS Workstation Crit... Class I Draeger Medical Systems, Inc.
Feb 3, 2014 The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is... The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one... Class I Hospira Inc.
Feb 3, 2014 The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is... The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one... Class I Hospira Inc.
Jan 31, 2014 Greatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, T10243, T1028... Greatbatch Medical has initiated a global Field Corrective Action for the Standard Offset Cup Imp... Class I Greatbatch Medical

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.