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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

2,522 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,522 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 2,522 FDA device recalls.

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DateProductReasonClassFirm
May 23, 2014 Sarns Malleable Venous Return Cannulae 24, 28, 30, 32, 34, 36 & 40 Fr single ... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
May 23, 2014 CPB Catheter Kit Product Usage: Venous Return Cannula is indicated for ve... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
May 23, 2014 Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer &... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
May 23, 2014 Terumo Three-stage Venous Return Cannulae 28 Fr with 3/8" flare, 30 Fr with 3... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
May 23, 2014 Sarns Venoatrial Cannulae 36/46 Fr with 1/2" flare or connector Product Us... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
May 23, 2014 Sarns Flexible Aortic Arch Cannula 8.0mm with luer, 3/8" connector Product... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
May 23, 2014 Terumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & ... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
May 23, 2014 Sarns Two-stage Venous Return Cannulae 32/40 & 36/51 Fr with 1/2" & 3/8" flar... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
May 23, 2014 Sarns Malleable Dual-stage Venous Return Cannulae 28/38, 32/40 & 34/46 Fr wit... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
May 23, 2014 Sarns D4 Aortic Arch Cannulae 6.0mm, 7mm & 8mm angled and straight tip with o... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
May 20, 2014 LAPAROSCOPY COLORECTAL SURGICAL PACK CONTENTS: (1) SOLUTION SURGICAL D... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 LAPAROSCOPIA COLORECTAL PACK CONTENTS: (1) SOLUTION SURGICAL DURAPREP ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 LAPAROSCOPY COLORECTAL SURGICAL PACK code 900-2259A, contains: (1) SOLUTIO... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 13, 2014 The Stryker NAV3i Platform is a mobile cart platform consisting of the sub-co... The Stryker NAV3i Platform Power Boxes produced between December 9, 2013 and March 7, 2014 may ha... Class II Stryker Instruments Div. of Stryker Corporation
Apr 30, 2014 PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Or... Difficulty removing the cup adaptor from the impaction handle during surgery Class II Microport Orthopedics INC.
Apr 29, 2014 Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Gene... Events related to a pacing rate outside of the intended setting, including events of sudden incre... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Apr 23, 2014 GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w ... GE Healthcare has recently become aware of a potential safety issue with certain GE MRI Products.... Class II GE Healthcare, LLC
Apr 21, 2014 Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt ... AIC (USA) received information regarding 3 complaints in which the deflector did not move freely ... Class II Aesculap, Inc.
Apr 16, 2014 HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - Heart... Patients and caregivers are instructed that if a battery does not provide two hours of support or... Class II HeartWare Inc
Apr 15, 2014 EZPass Suture Retriever, Nitinol, Single Pack, Part number 10007380. Orthope... The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked mak... Class II Biomet, Inc.
Apr 15, 2014 EZPass Passer, Sterile single use arthroscopic instrument utilized in conjunc... The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked mak... Class II Biomet, Inc.
Apr 15, 2014 EZPass Nylon Monofilament Single Pack, Part number 110007379, Orthopedic Manu... The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked mak... Class II Biomet, Inc.
Apr 7, 2014 SBi RingFix Olive Wires Product Usage: These are temporary devices indica... Small Bone Innovations (SBI) is recalling non-sterile RingFIX Olive Wires labeled as item #451-30... Class II Small Bone Innovations, Inc.
Mar 27, 2014 INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version... An anomaly impacts the monitoring system of INOmax DSIR Plus (software 3.0.0). When the integrat... Class II INO Therapeutics (dba Ikaria)
Mar 27, 2014 Sit/stand Rolling Walker, SKU/Item Number 66838. Intended for use by those w... Harbor Freight Tools intiaited a recall of Sit/Stand Rolling Walker (SKU/Item Number 66838, sold ... Class II Central Purchasing LLC DBA Harbor Freight Tools
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.

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.