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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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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 8, 2013 The LifeCare PCA Plus II infusion pump system is designed for safe, effective... Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted ... Class II Hospira Inc.
Mar 8, 2013 Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal ... Recall is being initiated due to the part being mislabeled (Part Number 241.267 was mislabeled wi... Class II Synthes USA HQ, Inc.
Mar 1, 2013 Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generato... An internal protective fuse can be unintentionally activated while the device is charging its cap... Class II Boston Scientific CRM Corp
Feb 22, 2013 Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 3... Kerr Corporation is initiating this recall because raw material used to produce the Maxcem Elite... Class II Kerr/Pentron, DBA Kerr Corporation and Pentron ...
Feb 18, 2013 Punch Hair Matic A surgical hair transplant device designed for automation... Medicamat is initiating a field correction due to misbranded marketing literature for the Punch H... Class II MEDICAMAT S.A.
Feb 11, 2013 Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm ... Single Use Loading Unit contained two staples loaded in each cartridge pocket and may result in d... Class II Covidien LP
Feb 5, 2013 SpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Dayt... The recall decision has been made because because it has recently been determined that the instru... Class II SpineNet
Feb 1, 2013 The Plum A+ Infusion Systems are a multipurpose family of devices that provid... A possible interruption of therapy when an E321 error code occurs while using the infuser, which ... Class II ICU
Feb 1, 2013 The Plum A+ Infusion Systems are a multipurpose family of devices that provid... A possible interruption of therapy when an E321 error code occurs while using the infuser, which ... Class II ICU
Feb 1, 2013 The Plum A+ Infusion Systems are a multipurpose family of devices that provid... A possible interruption of therapy when an E321 error code occurs while using the infuser, which ... Class II ICU
Feb 1, 2013 The Plum A+ Infusion Systems are a multipurpose family of devices that provid... A possible interruption of therapy when an E321 error code occurs while using the infuser, which ... Class II ICU
Feb 1, 2013 The Plum A+ Infusion Systems are a multipurpose family of devices that provid... A possible interruption of therapy when an E321 error code occurs while using the infuser, which ... Class II ICU
Feb 1, 2013 The Plum A+ Infusion Systems are a multipurpose family of devices that provid... A possible interruption of therapy when an E321 error code occurs while using the infuser, which ... Class II ICU
Feb 1, 2013 The Plum A+ Infusion Systems are a multipurpose family of devices that provid... A possible interruption of therapy when an E321 error code occurs while using the infuser, which ... Class II ICU
Feb 1, 2013 The Plum A+ Infusion Systems are a multipurpose family of devices that provid... A possible interruption of therapy when an E321 error code occurs while using the infuser, which ... Class II ICU
Feb 1, 2013 The Plum A+ Infusion Systems are a multipurpose family of devices that provid... A possible interruption of therapy when an E321 error code occurs while using the infuser, which ... Class II ICU
Jan 28, 2013 Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. ... Isoline defibrillation leads distributed may have internal insulation breach. Class II Sorin Group USA, Inc.
Jan 24, 2013 Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC345... Firm was made aware of incidents relating to the difficulty of properly engaging and securing the... Class II Stelkast Co
Jan 14, 2013 LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healt... Out of an abundance of caution, Ansell is implementing a voluntary recall of the Zero Latex Condo... Class II Ansell Healthcare Products LLC
Jan 14, 2013 Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate... Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labe... Class II Atricure Inc
Dec 27, 2012 Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosen... Class II Heartware Inc
Dec 13, 2012 Ortho Clinical Diagnostics VITROS¿ Chemistry Products Vapor Adsorption Cartri... Some VITROS¿ Chemistry Products Vapor Adsorption Cartridge CAT No. 6800100 cartons incorrectly co... Class II Ortho-Clinical Diagnostics
Dec 7, 2012 Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; ... The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break... Class II Hospira Inc.
Dec 7, 2012 Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045;... The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break... Class II Hospira Inc.
Dec 5, 2012 Companion External Battery, Part Number: 293001-001 The Companion External... Syncardia Systems is recalling the Companion External Batteries used with the Companion 2 Driver ... Class II SynCardia Systems Inc.
Dec 3, 2012 SOL SYS 8IN CALCAR SZ12 Packaging: Product is packed within a poly protect... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS L 9IN CALC 2.25/16.5 Packaging: Product is packed within a poly pr... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS F 9 CALC L 13.5MM LG Packaging: Product is packed within a poly pr... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS R 9IN CALC 2.25/22.5 Packaging: Product is packed within a poly pr... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS L 9IN CALC 2.25/18 Packaging: Product is packed within a poly prot... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS L 9IN CALC 2.25/21 Packaging: Product is packed within a poly prot... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS 8IN CALC 1.5/15.0 Packaging: Product is packed within a poly prote... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS 8IN CALC 1.5/16.5 Packaging: Product is packed within a poly prote... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS R 9IN CALC 2.25/15.0 Packaging: Product is packed within a poly pr... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS F 9 CALC L 13.5MM LG Packaging: Product is packed within a poly pr... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS L 9IN CALC 2.25/22.5 Packaging: Product is packed within a poly pr... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS R 9IN CALC 2.25/19.5 Packaging: Product is packed within a poly pr... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS R 9IN CALC 2.25/21 Packaging: Product is packed within a poly prot... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS R 9IN CALC 2.25/18 Packaging: Product is packed within a poly prot... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS F 8 CALC 13.5MM LG Packaging: Product is packed within a poly prot... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS L 9IN CALC 2.25/19.5 Packaging: Product is packed within a poly pr... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS 8IN CALC 1.5/19.5 Packaging: Product is packed within a poly prote... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS R 9IN CALC 2.25/16.5 Packaging: Product is packed within a poly pr... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS L 9IN CALC 2.25/15.0 Packaging: Product is packed within a poly pr... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS 8IN CALC 1.5/18.0 Packaging: Product is packed within a poly prote... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Nov 27, 2012 Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR m... Siemens has confirmed customer complaints of low patient sample recovery with Dimension(R) TACR F... Class II Siemens Healthcare Diagnostics, Inc.
Nov 26, 2012 Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag,... Surgical procedure trays are packed with pharmaceuticals for injection that may contain particula... Class II Custom Healthcare Systems, Inc.
Nov 26, 2012 Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in... Surgical procedure trays are packed with pharmaceuticals for injection that may contain particula... Class II Custom Healthcare Systems, Inc.
Nov 19, 2012 Coonrad/Morrey New Ulnar Revision Kit for Use with Non-Interchangeable Regula... Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inn... Class II Zimmer, Inc.
Nov 19, 2012 COONMAD/MORREY TOTAL ELBOW ELBOW COMPONENT REPLACEMENT SET BUSHINGS & PINS ... Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inn... Class II Zimmer, 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.