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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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Browse Device Recalls

2,447 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,447 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 2,447 FDA device recalls.

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DateProductReasonClassFirm
Mar 17, 2014 SHAPE ARM, SINGLE, an articulating, arm bracket that is attached to the servi... During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the S... Class II Stryker Communications
Mar 17, 2014 BAM (SHAPE) ARM, LEFT, an articulating, arm bracket that is attached to the s... During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the S... Class II Stryker Communications
Mar 17, 2014 BAM (SHAPE) ARM, RIGHT, an articulating, arm bracket that is attached to the ... During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the S... Class II Stryker Communications
Mar 17, 2014 SHAPE ARM, DUAL SH2, an articulating, arm bracket that is attached to the ser... During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the S... Class II Stryker Communications
Mar 17, 2014 SHAPE ARM, SINGLE WITH GCX MOUNT, an articulating, arm bracket that is attach... During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the S... Class II Stryker Communications
Mar 11, 2014 5/10/12 mm Weck¿ Vista" Universal Cannula, Product Usage: An endoscope ... Complaints were received of leakage of insufflation gas through the device, which can cause diffi... Class II Teleflex Medical
Mar 11, 2014 5/10 Weck¿ Vista" Universal Balloon Open Access Port - Standard Length (70mm)... Complaints were received of leakage of insufflation gas through the device, which can cause diffi... Class II Teleflex Medical
Mar 11, 2014 5/10 mm Weck¿, Vista" Universal Cannula, Teleflex Medical, Product Usage:... Complaints were received of leakage of insufflation gas through the device, which can cause diffi... Class II Teleflex Medical
Mar 11, 2014 5/10/12 Weck¿ Vista" Universal Balloon Open Access Port  Standard Length (70... Complaints were received of leakage of insufflation gas through the device, which can cause diffi... Class II Teleflex Medical
Mar 11, 2014 Weck¿ Vista" Universal Laparoscopic Port, Size 5/10/12mmx125mm, Product U... Complaints were received of leakage of insufflation gas through the device, which can cause diffi... Class II Teleflex Medical
Mar 11, 2014 Weck¿ Vista" Universal Laparoscopic Port, Size 5/10/12mmx100mm, Product U... Complaints were received of leakage of insufflation gas through the device, which can cause diffi... Class II Teleflex Medical
Mar 11, 2014 5/10/12MM X 100MM Weck¿ Vista" UNIVERSAL CONE OPEN ACCESS, Product Usage:... Complaints were received of leakage of insufflation gas through the device, which can cause diffi... Class II Teleflex Medical
Mar 11, 2014 12mm Weck¿ Vista" Cannula-only, Teleflex Medical, Product Usage: An en... Complaints were received of leakage of insufflation gas through the device, which can cause diffi... Class II Teleflex Medical
Mar 11, 2014 5/10/12 Weck¿ Vista" Universal Balloon Open Access Port  Long Length (100mm)... Complaints were received of leakage of insufflation gas through the device, which can cause diffi... Class II Teleflex Medical
Mar 11, 2014 5/10 Weck¿ Vista" Universal Balloon Open Access Port  Short Length (53mm), ... Complaints were received of leakage of insufflation gas through the device, which can cause diffi... Class II Teleflex Medical
Mar 11, 2014 10mm Weck¿ Vista" Cannula-only, Teleflex Medical, Product Usage: An en... Complaints were received of leakage of insufflation gas through the device, which can cause diffi... Class II Teleflex Medical
Mar 11, 2014 5/10 Weck¿ Vista" Universal Balloon Open Access Port - Long Length (100mm), ... Complaints were received of leakage of insufflation gas through the device, which can cause diffi... Class II Teleflex Medical
Mar 11, 2014 Weck¿ Vista", Universal Laparoscopic Port, Size 5/10mmx100mm, Product Usa... Complaints were received of leakage of insufflation gas through the device, which can cause diffi... Class II Teleflex Medical
Mar 11, 2014 5/10 mm Weck¿, Vista" Optical Bladeless Laparoscopic Access Port, Product... Complaints were received of leakage of insufflation gas through the device, which can cause diffi... Class II Teleflex Medical
Mar 11, 2014 5/10/12 mm Weck¿ Vista" Optical Bladeless Laparoscopic Access Port, Produ... Complaints were received of leakage of insufflation gas through the device, which can cause diffi... Class II Teleflex Medical
Mar 3, 2014 Morph AccessPro Steerable Introducer; 6F Introducer, 45 cm working length S... Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable I... Class II Biocardia, Inc.
Mar 3, 2014 Morph AccessPro Steerable Introducer; 6F Introducer, 90 cm working length: ... Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable I... Class II Biocardia, Inc.
Feb 20, 2014 PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Cat... Biosense Webster is recalling the PentaRay Nav Catheter because it has the potential to have part... Class II Biosense Webster, Inc.
Feb 18, 2014 Philips HeartStart MRx Monitor/Defibrillator; Models: M3535A, M3536A, M3536J... ECG trunk cable and connector block of the MRx could be susceptible to accelerated wear, which co... Class II Philips Medical Systems, Inc.
Feb 18, 2014 HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J... Philips HeartStart MRx Monitor/Defibrillator, when operating on battery power only, may experienc... Class II Philips Medical Systems, Inc.
Feb 18, 2014 HeartStart MRx Monitor/Defibrillator; Model(s), Catalogue, or Code Number: M... A component of the MRx Processor Board may be susceptible to damage from electrostatic discharge ... Class II Philips Medical Systems, Inc.
Feb 18, 2014 Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with ... When the HeartStart MRx.is used with the Q-CPR Meter in defibrillation mode, the Q-CPR Meter may ... Class II Philips Medical Systems, Inc.
Feb 18, 2014 M3536A HeartStart MRx with Wireless Link Upgrade (861289) The HeartStart M... Wireless Link may be unable to transmit data when configured for a specific data flow. Class II Philips Medical Systems, Inc.
Feb 13, 2014 GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.... GE Healthcare has recently become aware of a potential safety issue with the Solar 8000M/i Patien... Class II GE Healthcare, LLC
Feb 12, 2014 CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog ... Biosense Webster has initiated a recall of the CartoUnivu Module within the Carto 3 System (V3.2... Class II Biosense Webster, Inc.
Feb 7, 2014 HER2 Image Analysis Manual Read of HER2 Digital Slides ER/PR Image Analysis... In an abundance of caution, Aperio (now known as Lecia Biosystems) is providing additional inform... Class II Leica Biosystems Imaging, Inc.
Feb 6, 2014 Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 ... Philip's is recalling HeartStart FR3 Automated External Defibrillator (AED) because the Printed C... Class II Philips Medical Systems North America Inc.
Feb 5, 2014 Product Brand Name(s): Alere Triage¿ TOX+MTD Drug Screen, Catalog Number 9440... Alere San Diego, Inc. is initiating a recall of the Alere Triage¿ TOX Drug Screen, Catalog Number... Class II Alere San Diego, Inc.
Jan 30, 2014 PRE1055US: Prevena Dressing, 5 Pack (US-ONLY) Product Usage: The Prevena ... Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... Class II KCI USA, INC.
Jan 30, 2014 PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY) P... Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... Class II KCI USA, INC.
Jan 30, 2014 PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena In... Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... Class II KCI USA, INC.
Jan 30, 2014 PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena ... Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... Class II KCI USA, INC.
Jan 30, 2014 PRE2001: Prevena Incision Management Customizable System Box Product Usage... Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... Class II KCI USA, INC.
Jan 30, 2014 PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) Product Usage: ... Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... Class II KCI USA, INC.
Jan 30, 2014 PRE1055: Prevena Dressing, 5 Pack Product Usage: The Prevena Incision Man... Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... Class II KCI USA, INC.
Jan 30, 2014 PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: Th... Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... Class II KCI USA, INC.
Jan 23, 2014 Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive,... The firm was notified by a customer of a cracked spring in the handle of the RCD1 device. Class II Atricure Inc
Jan 22, 2014 SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless ... CareFusion is recalling the SmartSite Needlefree Connector, model number 2000E, because of connec... Class II CareFusion 303, Inc.
Jan 20, 2014 Crimper Model 9100CR26 The Crimper is indicated for use in preparing the E... Edwards Lifesciences is recalling two lot numbers of the 26mm transcatheter heart valve crimper b... Class II Edwards Lifesciences, LLC
Jan 9, 2014 Restoris Multicompartmental Knee (MCK) System is an implant system designed t... The product may be mislabeled and could result in the incorrect implant being used. Class II Mako Surgical Corporation
Jan 7, 2014 Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia ... The Synthes Driving Cap/Threaded can bind in the IM Nail Radiolucent Insertion Handles when assem... Class II Synthes, Inc.
Dec 24, 2013 10" (25 cm) Appx 0.38 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoCl... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 8" (20 cm) Appx 0.51 ml, Smallbore Ext Set w/MicroCLAVE¿ Clear, 0.2 Micron F... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/2 NanoClave", Clamp, Rotating L... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 87" (221 cm) Appx 2.9 ml, Smallbore Trifuse Ext Set w/NanoClave¿, 0.2 Micron... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.

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.