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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

5,543 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.

Clear
DateProductReasonClassFirm
Aug 22, 2019 The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double ... Based on an internal incident report, Getinge/Intervascular SAS has identified that the one (1) H... Class II GETINGE US SALES LLC
Aug 21, 2019 Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthop... Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the... Class II Zimmer GmbH
Aug 21, 2019 CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large... Possible suture brittleness or breakage along the Envelope seam before the expiration date of the... Class II AZIYO BIOLOGICS
Aug 21, 2019 Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled a... Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL)... Class II Boston Scientific Corporation
Aug 21, 2019 BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEn... Possible suture brittleness or breakage along the Envelope seam before the expiration date of the... Class II AZIYO BIOLOGICS
Aug 21, 2019 Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled a... Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL)... Class II Boston Scientific Corporation
Aug 20, 2019 20" 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous Safety Needle Sets" Product... Mislabeled needle lengths Class II Repro-Med Systems, Inc.
Aug 15, 2019 QuickGraft¿ Model # 430PST Measurement listed on the label is not taken under tension, and this would cause possible extensi... Class II Musculoskeletal Transplant Foundation, Inc.
Aug 13, 2019 VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1... Firm identified a subset of its generators that were sterilized one additional sterilization cycl... Class II LivaNova USA Inc
Jul 30, 2019 Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h X-ray imaging system positioning image and protocol label is reversed for Flexion and Extension o... Class II Shanghai United Imaging Healthcare Co., Ltd.
Jul 29, 2019 Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... Class II ICU Medical Inc
Jul 29, 2019 Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... Class II ICU Medical Inc
Jul 29, 2019 Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... Class II ICU Medical Inc
Jul 29, 2019 Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... Class II ICU Medical Inc
Jul 29, 2019 Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... Class II ICU Medical Inc
Jul 29, 2019 Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... Class II ICU Medical Inc
Jul 29, 2019 Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... Class II ICU Medical Inc
Jul 29, 2019 Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... Class II ICU Medical Inc
Jul 29, 2019 Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... Class II ICU Medical Inc
Jul 29, 2019 Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... Class II ICU Medical Inc
Jul 29, 2019 Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... Class II ICU Medical Inc
Jul 29, 2019 Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... Class II ICU Medical Inc
Jul 29, 2019 Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... Class II ICU Medical Inc
Jul 29, 2019 Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... Class II ICU Medical Inc
Jul 29, 2019 Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... Class II ICU Medical Inc
Jul 29, 2019 Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... Class II ICU Medical Inc
Jul 29, 2019 Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... Class II ICU Medical Inc
Jul 29, 2019 Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... Class II ICU Medical Inc
Jul 29, 2019 Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... Class II ICU Medical Inc
Jul 29, 2019 Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... Class II ICU Medical Inc
Jul 29, 2019 Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... Class II ICU Medical Inc
Jul 29, 2019 Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... Class II ICU Medical Inc
Jul 22, 2019 Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems. Reversed expiration and manufacturing date on the label Class II GETINGE US SALES LLC
Jul 19, 2019 AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: ... Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore.. Class II Boston Scientific Corporation
Jul 19, 2019 NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Onl... The top label for dental implant may incorrectly indicate the implant length. Specifically, the l... Class II Nobel Biocare Usa Llc
Jul 17, 2019 U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urod... Power supply unit (PS-SBL) not correctly labeled, and insulation material used at the low voltage... Class II LABORIE MEDICAL TECHNOLOGIES, CORP
Jul 16, 2019 xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral ... The Assay may give a false negative result when detecting and subtyping Influenza A (H3) and dete... Class II Luminex Molecular Diagnostics
Jul 11, 2019 Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1 Potential for prior thumbnails to not display in reverse chronological order and images may not s... Class II Merge Healthcare, Inc.
Jul 11, 2019 Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1 Potential for prior thumbnails to not display in reverse chronological order and images may not s... Class II Merge Healthcare, Inc.
Jul 8, 2019 GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled ... Potential for certain GRIPPER Needles to contain an occluded or blocked needle. Class II Smiths Medical ASD Inc.
Jul 8, 2019 GRIPPER Needles sold individually. Labeled as the following item description... Potential for certain GRIPPER Needles to contain an occluded or blocked needle. Class II Smiths Medical ASD Inc.
Jul 3, 2019 PediaLift Access Device, Device Identifier: B751PDLFT0 The firm was unsuccessful in obtaining a satisfactory Certificate of Conformance from the origi... Class II PediaLift LLC
Jul 3, 2019 CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Elect... Possible mis-labeling of the device with incorrect serial number labels which may result in a pat... Class II Capso Vision, Inc.
Jun 27, 2019 AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .01... The affected product is properly labelled with an expiration date of March 31, 2022; but the RFID... Class II Angiodynamics, Inc.
Jun 24, 2019 IQon Spectral CT Model # 728332, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... Class II Philips Medical Systems (Cleveland) Inc
Jun 24, 2019 Vereos PET/CT Model # 882446, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... Class II Philips Medical Systems (Cleveland) Inc
Jun 24, 2019 Ingenuity Core Model # 728321, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... Class II Philips Medical Systems (Cleveland) Inc
Jun 24, 2019 iCT SP Model # 728311, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... Class II Philips Medical Systems (Cleveland) Inc
Jun 24, 2019 Ingenuity TF PET/CT Model # 882456, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... Class II Philips Medical Systems (Cleveland) Inc
Jun 24, 2019 Ingenuity CT, Model # 728326, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... Class II Philips Medical Systems (Cleveland) 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.