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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

5,424 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,424 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 5,424 FDA device recalls.

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DateProductReasonClassFirm
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
Jan 20, 2023 Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Mo... Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the hea... Class III SUREPULSE MEDICAL LTD
Jan 20, 2023 SenSight Connector Plug, Model Number B31061. Medtronic is requesting return of a small number of units of the SenSight Connector Plug, Model B... Class II Medtronic Neuromodulation
Jan 20, 2023 Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate M... 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 Large REF: SP-162-A1 component of VS Newborn Heart Rate Mo... Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the hea... Class III SUREPULSE MEDICAL LTD
Jan 18, 2023 Sprint 200 wheeled stretcher, Item numbers 1ES200-7, 1ES210-1, and 1ES211-1. Labeling being updated to assure user is securing the siderail to a locked position to prevent po... Class II Linet Spol. S.r.o.
Jan 5, 2023 abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler REF B... Incorrect expiration date on product label. The manufacturing date was listed as the expiration ... Class III S & MOHR AMERICA, S.A. DE C.V.
Jan 3, 2023 FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloop... Face masks were placed into the incorrect dispenser boxes. The face masks come with ear loops, bu... Class III Owens & Minor Distribution, Inc.
Dec 29, 2022 (1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee... Components Incorrectly labeled as either smaller or larger and incorrect side (right/left). Class II Biomet, Inc.
Dec 29, 2022 (1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended for Kne... Components Incorrectly labeled as either smaller or larger and incorrect side (right/left). Class II Biomet, Inc.
Dec 23, 2022 Incisive CT, model 728143 & 728144 running Software Version 5.0.0. Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts ... Class II Philips Healthcare (Suzhou) Co., Ltd.
Dec 22, 2022 AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size ... There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed... Class II SunMed Holdings, LLC
Dec 22, 2022 EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706; EMPOWR VVC KNEE... Tibial insert implant large boxes were labeled small and the small boxes were labeled large. If t... Class II Encore Medical, LP
Dec 22, 2022 Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow l... In the syngo.CT VA40 and syngo.CT VA50 myNeedle Guide application, the order of the orientation l... Class II Siemens Medical Solutions USA, Inc
Dec 22, 2022 HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term acce... Label with the incorrect component listed on the inner kit Tyvek header bag Class II Access Vascular, Inc
Dec 22, 2022 Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size RE... There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed... Class II SunMed Holdings, LLC
Dec 22, 2022 HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term acc... Product Mislabeled on the outer bag and inner kit Tyvek header bag Class II Access Vascular, Inc
Dec 16, 2022 HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001 Select catheter lots were identified to be labeled with incorrect expiration date, where the cath... Class II Access Vascular, Inc
Dec 16, 2022 HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002 Select catheter lots were identified to be labeled with incorrect expiration date, where the cath... Class II Access Vascular, Inc
Dec 16, 2022 Mammotome MammoStar Biopsy Site Identified, REF STAR1401 The label incorrectly identifies the product as STAR1401, a 1x3mm Barbell shaped marker pre-loade... Class II Carbon Medical Technologies, 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.