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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

5,543 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,543 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 5,543 FDA device recalls.

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DateProductReasonClassFirm
Mar 21, 2023 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item ... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Numb... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 50MM Item Number: 1... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 50MM Item Number:... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM I... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ENDO SLED KNEE FEM COMP, Large Item Number: 15-202... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 45MM Item Numbe... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM It... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13X58MM Item Number: 1... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number:... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, SMALL Item Number: ... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM Item Number... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 55MM Item Number... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM It... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item N... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 50MM Item Numbe... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 58MM Item Number: 1... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 20, 2023 DERMLITE DL4W, REF: DL4W, Rx Only MD, CE Incorrect labeling; Package labeling contains a different serial number then the serial number on... Class II DermLite LLC
Mar 16, 2023 (1) Carefusion V. Mueller Graves Vaginal Speculum, Catalog #GL11, Medium Blad... A portion of the two products were incorrectly marked (etched) and packaged resulting in a produc... Class II Carefusion 2200 Inc
Mar 9, 2023 DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1... The instruction manual is being replaced with an updated version that is in alignment with labeli... Class II DeVilbiss Healthcare LLC
Mar 3, 2023 CombiDiagnost R90 R1.1 Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 ... Class II Philips North America
Mar 3, 2023 CombiDiagnost R90 R.1.0 Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 ... Class II Philips North America
Mar 3, 2023 ProxiDiagnost N90 R.1.0 Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 ... Class II Philips North America
Feb 23, 2023 Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cer... Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955... Class II Aesculap Implant Systems LLC
Feb 21, 2023 PCRopsis Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swa... Presence of misleading label statements on the product label. Class II Entopsis , Inc.
Feb 21, 2023 PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid ... Presence of misleading label statements on the product label. Class II Entopsis , Inc.
Feb 21, 2023 Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), RE... Incorrect labeling; specifically, the product name, lot number and product code on the carton lab... Class II Biosense Webster, Inc.
Feb 21, 2023 PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025... Presence of misleading label statements on the product label. Class II Entopsis , Inc.
Feb 21, 2023 Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF... Incorrect labeling; specifically, the product name, lot number and product code on the carton lab... Class II Biosense Webster, Inc.
Feb 21, 2023 PCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, RE... Presence of misleading label statements on the product label. Class II Entopsis , Inc.
Feb 21, 2023 PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety o... Presence of misleading label statements on the product label. Class II Entopsis , Inc.
Feb 21, 2023 PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 7... Presence of misleading label statements on the product label. Class II Entopsis , Inc.
Feb 21, 2023 PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825... Presence of misleading label statements on the product label. Class II Entopsis , Inc.
Feb 15, 2023 KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), u... Battery packs used in surgical procedures where a surgeon uses a powered screwdriver and a right-... Class II Pro-Dex Inc
Feb 6, 2023 G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Nu... The outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 3... Class II Biomet, Inc.
Feb 1, 2023 TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intende... TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nail... Class II Synthes (USA) Products LLC
Feb 1, 2023 BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein... New warnings and precautionary statements on product labelling: Reagent 2 (R2) of BIOPHEN Protein... Class II Aniara Diagnostica LLC
Feb 1, 2023 TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intende... TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nail... Class II Synthes (USA) Products LLC
Feb 1, 2023 TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intende... TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nail... Class II Synthes (USA) Products LLC
Feb 1, 2023 PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials... Product is labeled with an incorrect expiration date. Class III Preat Corp
Jan 25, 2023 Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L ... Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output... Class II Stryker Corporation
Jan 25, 2023 Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L ... Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output... Class II Stryker Corporation
Jan 25, 2023 Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the ... Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output... Class II Stryker Corporation
Jan 25, 2023 TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt ... Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in... Class II Limacorporate S.p.A
Jan 20, 2023 Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart R... Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the hea... Class III SUREPULSE MEDICAL LTD
Jan 20, 2023 Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart R... Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the hea... Class III SUREPULSE MEDICAL LTD

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.