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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

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
Jan 19, 2021 Heartspan Transseptal Needles, Catalog No. FND-019-02, Lot No. E1913645 consi... The labeled needle tip curvature of specific lots of transseptal needles may not match the actual... Class II Merit Medical Systems, Inc.
Jan 19, 2021 Various reprocessed products: PROVISION, Reprocessed Smith and Nephew Arthr... Non-sterile product was shipped to customers labelled as sterile. Class II ReNovo, Inc.
Jan 15, 2021 Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is inten... Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Sh... Class II Biomet, Inc.
Jan 14, 2021 BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm R... Due to the Penetration Depth Switch used to select the desired penetration depth of the biopsy ne... Class II Bard Peripheral Vascular Inc
Jan 13, 2021 Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - ... incorrect device is contained in the package. The packaging label indicates that the device is fo... Class II Covidien Llc
Jan 12, 2021 Grasper/Retriever, Alligator Jaw 2.4 mm x 5 mm x 230 cm Catalog Number: 7208 ... Mislabeled: Devices labeled as catalog #7208 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 2... Class II Shent USA, Inc.
Jan 12, 2021 Grasper/Retriever, Alligator Jaw, Rat Tooth 2.4 mm x 8 mm x 230 cm Catalog ... Mislabeled: Devices labeled as catalog #7208 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 2... Class II Shent USA, Inc.
Jan 7, 2021 BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In... Some N1 and N2 master mix pouches packaged within the lots of BioGX SARS-CoV-2 Reagents for BD MA... Class II Becton Dickinson & Co.
Dec 30, 2020 ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on th... The Quality Control (QC) card has a label error for the standard deviation (SD) values for one ou... Class II Beckman Coulter Inc.
Dec 22, 2020 Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-... FUJIFILM has become aware that incorrect concentration values were printed on the bottle label fo... Class III Fujifilm Medical Systems U.S.A., Inc.
Dec 22, 2020 Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2... Users may observe very faint additional locus specific signals at 11q13. There is a low risk of a... Class II Cytocell Ltd.
Dec 21, 2020 PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No.... Medical device non-conformance to electrical safety standard (IEC 60601-1). Class II Nihon Kohden America Inc
Dec 18, 2020 AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, ... Labeling update; To reduce the risk of false positive/false negative results the IFU for the adap... Class II Ansh Labs, LLC
Dec 17, 2020 Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concent... Bottles Missing Product Label Class II Fresenius Medical Care Holdings, Inc.
Dec 16, 2020 KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affecte... The expiration date on the label of one component (negative control 0243U) in the set lot is inco... Class III Microbiologics Inc
Dec 14, 2020 Neuroreader Medical Image Processing Software - Product Usage: intended to au... The Neuroreader has been distributed with a reference normative database that is different from ... Class II Brainreader ApS
Dec 14, 2020 Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use... Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled ... Class II Integra LifeSciences Corp.
Dec 14, 2020 Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: u... Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled ... Class II Integra LifeSciences Corp.
Dec 10, 2020 Clerio Vision, extreme H2O monthly, MED, DIA 14.0 PWR -2.25, UPC 675506803334... One lot of contact lenses labeled as BC MED, DIA 14.0 PWR -2.25 contained BC MED, DIA 14.0, PWR -... Class II Clerio Vision
Dec 8, 2020 smiths medical portex Loss of Resistance Device, REF 100/398/000 The labeling was missing information on sterilization and prohibition of reuse. Class II Smiths Medical ASD Inc.
Dec 5, 2020 visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitativ... Two issues: 1) 5 Lots were found to have incorrect labeling on the outer box stating that the pr... Class II VISBY MEDICAL INC
Dec 2, 2020 Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per cas... Purple ink located on the outside label of Vis-U-All Pouches may migrate (bleed) following steam ... Class II Steris Corporation
Dec 2, 2020 Vis-U-All High Temperature Tubing 3"x100'. One roll per box; 10 boxes per cas... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea... Class II Steris Corporation
Dec 2, 2020 Stryker Medela REF 077.0193 AXS Universal Aspiration Tubing (01)0761236705392... Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date sh... Class II Medela AG Medical Technology
Dec 2, 2020 Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea... Class II Steris Corporation
Dec 2, 2020 Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea... Class II Steris Corporation
Dec 2, 2020 Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per c... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea... Class II Steris Corporation
Dec 2, 2020 Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per c... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea... Class II Steris Corporation
Dec 2, 2020 Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per c... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea... Class II Steris Corporation
Dec 2, 2020 Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea... Class II Steris Corporation
Dec 2, 2020 Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per cas... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea... Class II Steris Corporation
Dec 2, 2020 Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per c... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea... Class II Steris Corporation
Dec 2, 2020 Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per ... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea... Class II Steris Corporation
Dec 2, 2020 Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per ... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea... Class II Steris Corporation
Dec 2, 2020 Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per cas... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea... Class II Steris Corporation
Dec 2, 2020 Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes p... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea... Class II Steris Corporation
Nov 20, 2020 VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product... A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may... Class II Ortho-Clinical Diagnostics, Inc.
Nov 20, 2020 enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN ... A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may... Class II Ortho-Clinical Diagnostics, Inc.
Nov 19, 2020 CM 50-001-01 Injectate Kit, accessory device to LiDCOunity v2 Monitor - Produ... The expiration date on labeling is incorrect. Class II Lidco Ltd
Nov 19, 2020 Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, ... Pumps manufactured with impellers from a subset of lots from a single supplier are failing to ini... Class I Heartware, Inc.
Nov 12, 2020 Stimulan Kit 10cc, Model 600-010 - Product Usage: intended for use as a bone ... The product is mislabeled. Class II Biocomposites, Ltd.
Nov 10, 2020 AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102... The products subject to this recall may contain obvious, incorrect pouch labels while the outer b... Class III Applied Medical Technology Inc
Nov 10, 2020 Product Code: K12T-02871, Revision A, Custom Procedure Kit, Embolization Kit ... Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting ... Class II Merit Medical Systems, Inc.
Nov 10, 2020 Custom Procedure Kit, Cardiac Cath Pack, Product Code: K12T-10996 Rev. B, Ste... Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting ... Class II Merit Medical Systems, Inc.
Nov 10, 2020 Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Onl... Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting ... Class II Merit Medical Systems, Inc.
Oct 30, 2020 DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); ac... The LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be misl... Class II Neocis, Inc.
Oct 23, 2020 Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23, ... Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant ball... Class II Medtronic Heart Valves Division
Oct 23, 2020 BD Ultra-Fine Pen Needles 32G x 4mm (5/32' )-intended for parenteral administ... Product shelf cartons incorrectly labeled as products intended for the Latin American market. Alt... Class II Becton Dickinson & Company
Oct 23, 2020 VGlove NITRILE *** Protect Your Life 100 Patient examination gloves Package labeled as nitrile gloves, contains latex gloves. Class II HUBO INTERNATIONAL INC
Oct 23, 2020 Evolut (TM) PRO+ System. With the following model numbers: a. EVPROPLUS... Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant ball... Class II Medtronic Heart Valves Division

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.