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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

3,264 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,264 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 3,264 FDA device recalls.

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DateProductReasonClassFirm
Oct 11, 2013 VERSA-FX II KEYLESS TUBE, VERSA-FX II KEYLESS SHORT, VERSA-FX II SHORT TUBE P... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 ONE-PIECE LAG SCREW 11MM. Item codes starting with 00225900. Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 6 DEGREE COCR FEM HEAD 36 Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 HGP II ACETABULAR CUP BON Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 HGP II ACETABULAR CUP MOD Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 MODULAR AUSTIN MOORE SOLI and MOORE HIP PROS REG SOLID Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 COMPRESSION SCREW (1/2, 1-1/2, 1-1/4, 1-3/4, 1. 2. 3/4 IN) Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 INTERLOCKING IM SCREW SML, MED and LRG; M/DN TIBIAL I/M NAIL 6 MM to 15 MM. ... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 M/DN HUMERAL I/M NAIL. Sizes from 6 MM to 13 MM. Codes starting with 0022541,... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes) Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 HERBERT BONE SCREW, 3.0MM and HERBERT CANNULATED BONE S Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 ASIA ONE-PIECE LAG SCREW Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 ZIMTRON 6 DEG 22 HEADS Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 DISTAL MEDIAL FEMORAL CON, DISTAL POSTERIOR/LATERAL, DISTAL SMALL VOLAR RADIU... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 3.5 COMP PLT, 4 HOLE 3.5 COMP PLT, 5 HOLE 3.5 COMP PLT, 6 HOLE ... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 RECON SCREW LG 5.5MM DIA and M/DN FEM IM NAIL 8MM DIA to 16 MM DIA. Item co... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 VERSA-FX KEYLESS 90D X 8 and X 11, VERSA-FX KEYLESS 95D X 8, X 11, and X 14, ... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 Magna-Fx Cannulated Screw Fixation System 7.0 mm. Item codes starting with 00... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 CPT 12/14 COCR (various sizes) Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENE... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 3.5 X 10 CORT SCREW SELFT 3.5 X 12 CORT SCREW SELFT 3.5 X 14 CORT SCREW SEL... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 PRESSFIT FEM ST FX 16 X 1 Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 1.5 X 6 CORT SCREW HEX/SE 2.0 X 6 CORT SCREW HEX/SE 2.0 X 10 CORT SCREW CRU... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 2.7 X 6 CORT SCREW/SELFTA 2.7 X 7 CORT SCREW/SELFTA 2.7 X 8 CORT SCREW/SELF... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 1, 2013 Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp. Stry... Stryker received a report from the field indicating that a 5.5 mm Cancellous Bone Screw 40 mm was... Class II Stryker Howmedica Osteonics Corp.
Oct 1, 2013 Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3 InHealth Technologies (IHT) is recalling the Blom-Singer Adjustable Tracheostoma Valve II (ATSV I... Class III Helix Medical LLC
Sep 26, 2013 3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics ... The firm identified, through complaints that the 3.5MM LOCKING SCREW packaging material was marke... Class II OrthoPediatrics Corp
Sep 23, 2013 Alere Triage¿ TOX Drug Screen Control 1 Product Generic Name: Quality Cont... Alere San Diego, Inc. initiated a voluntary recall of Alere Triage TOX Drug Screen Control 1 (PN ... Class III Alere San Diego, Inc.
Sep 10, 2013 Dual Luer Lock Cap The device is intended for use as a cap for male or fem... The firm is recalling lots 10043 and 10044 due to loose particulate matter found in the packaging... Class II Baxter Healthcare Corp.
Sep 4, 2013 Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 ... The firm is issuing a voluntary recall due to the potential for pinholes in the packaging. Pinhol... Class II Baxter Healthcare Corp.
Aug 28, 2013 VerSys¿ Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Herit... Based on a review of historic packaging validations, it was determined that a subset of product p... Class II Zimmer, Inc.
Aug 28, 2013 Ti-Magna Fx Washer Ti-Versa-FX¿II Femoral Fixation System S/C Plates Th... Zimmer recently conducted a review of historic packaging validations completed. Based on this re... Class II Zimmer, Inc.
Jul 31, 2013 "***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors ... The Edwards Lifesciences FloTrac Sensor is being recalled due to a manufacturing non-conformance ... Class II Edwards Lifesciences, LLC
Jul 30, 2013 Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fi... Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect label... Class II Synthes USA HQ, Inc.
Jul 30, 2013 Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment... The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole... Class II Synthes USA HQ, Inc.
Jul 30, 2013 Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject P... Complaints were received of inconsistencies in the expiration dates shown on the packaging of the... Class II Synthes USA HQ, Inc.
Jul 25, 2013 STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization Sys... The recall of the STERRAD 100NX Cassettes was initiated because Advanced Sterilization Products (... Class II Advanced Sterilization Products
Jul 24, 2013 GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, St... On April 29, 2013 Olympus Surgical Technologies America R&D received results from an accelerated... Class II Gyrus Medical, Inc
Jul 24, 2013 3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System ... OrthoPediatrics has initiated a voluntary recall of Part # 01-1050-002, 2.5mm Drill Bit, Lot #913... Class II OrthoPediatrics Corp
Jul 19, 2013 C-QUR TacShield Mesh (All sizes and shapes). Intended for use in soft tiss... Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner pac... Class II Atrium Medical Corporation
Jul 19, 2013 C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficienc... Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner pac... Class II Atrium Medical Corporation
Jul 19, 2013 C-QUR V-Patch Mesh (All sizes and shapes). Intended for use in soft tissue... Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner pac... Class II Atrium Medical Corporation
Jul 19, 2013 C-QUR Edge Mesh (All sizes and shapes). Intended for use in soft tissue de... Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner pac... Class II Atrium Medical Corporation
Jul 16, 2013 Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Ste... Zimmer recently conducted a review of historic packaging validations completed. Based on this re... Class II Zimmer, Inc.
Jul 8, 2013 Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis. the white printed paper layer on the pouch packaging may not be fully adhered to the pouch foil ... Class II Baxter Healthcare Corp.
Jun 25, 2013 ConvaTec Flexi-Seal SIGNAL Fecal Management System, Rx Only Product Usage:... ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occu... Class III Convatec Inc.
Jun 25, 2013 ConvaTec Flexi-Seal SIGNAL +, Rx Only Product Usage: For use to manage f... ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occu... Class III Convatec Inc.
Jun 24, 2013 SC2316, Distal Femoral Augment with Screw Total knee replacement due to os... The firm became aware of an incident relating to a breach of sterility in the sterility barrier p... Class II Stelkast Co
Jun 19, 2013 VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW, several length (55 m... Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t... Class II Zimmer, Inc.
Jun 19, 2013 VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and shor... Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t... 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.