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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

Infrastructure

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

3,629 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,629 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 3,629 FDA device recalls, Class I.

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DateProductReasonClassFirm
Jul 30, 2026 BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit ... After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or im... Class I Bard Access Systems, Inc.
Jul 15, 2026 BMC/REACTHEALTH Luna G3 APAP REF LG 3600 Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse Class I BMC Medical Co., Ltd.
Jul 9, 2026 Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Numb... Potential for arterial sheath tip separation or partial tip separation during use. Class I Boston Scientific Corporation
Jul 9, 2026 Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material... Potential for arterial sheath tip separation or partial tip separation during use. Class I Boston Scientific Corporation
Jul 6, 2026 Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride I... Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance... Class I Spectra Medical Devices, Llc
Jun 30, 2026 Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507;... Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cu... Class I Baxter Healthcare Corporation
Jun 25, 2026 Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that pro... Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage t... Class I ResMed Ltd.
Jun 17, 2026 INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INF... Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may re... Class I Boston Scientific Neuromodulation Corporation
Jun 11, 2026 ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 2... A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... Class I Abiomed, Inc.
Jun 11, 2026 ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containi... A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... Class I Abiomed, Inc.
Jun 11, 2026 ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP;... A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... Class I Abiomed, Inc.
Jun 11, 2026 ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; co... A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... Class I Abiomed, Inc.
Jun 11, 2026 ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Produc... A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... Class I Abiomed, Inc.
Jun 11, 2026 ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containi... A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... Class I Abiomed, Inc.
Jun 11, 2026 ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; ... A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... Class I Abiomed, Inc.
Jun 11, 2026 ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, cont... A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... Class I Abiomed, Inc.
Jun 11, 2026 ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Produc... A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... Class I Abiomed, Inc.
Jun 11, 2026 ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Intro... A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... Class I Abiomed, Inc.
Jun 11, 2026 ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550,... A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... Class I Abiomed, Inc.
Jun 11, 2026 ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, cont... A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... Class I Abiomed, Inc.
Jun 11, 2026 ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella In... A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... Class I Abiomed, Inc.
Jun 10, 2026 Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Int... Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to lea... Class I Oscor Inc.
Jun 10, 2026 Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Int... Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to lea... Class I Oscor Inc.
Jun 10, 2026 Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Int... Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to lea... Class I Oscor Inc.
Jun 8, 2026 MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline ... The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochl... Class I Medline Industries, LP
Jun 8, 2026 MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Med... The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochl... Class I Medline Industries, LP
Jun 5, 2026 MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT, Medline Kit SKU D... Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenie... Class I Medline Industries, LP
Jun 5, 2026 MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835;... Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenie... Class I Medline Industries, LP
Jun 5, 2026 MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenie... Class I Medline Industries, LP
Jun 1, 2026 Bone Marrow Tray, REF: CB0033TL; CB0355TLA Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall reca... Class I Argon Medical Devices, Inc
Jun 1, 2026 T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall reca... Class I Argon Medical Devices, Inc
Jun 1, 2026 One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall reca... Class I Argon Medical Devices, Inc
Jun 1, 2026 Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF... Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall reca... Class I Argon Medical Devices, Inc
Jun 1, 2026 Arterial Line Kit 20ga x 6, REF: 400115A Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall reca... Class I Argon Medical Devices, Inc
Jun 1, 2026 General Biospy Tray, REF: GUTS1000 Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall reca... Class I Argon Medical Devices, Inc
May 29, 2026 Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with... Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to v... Class I Hamilton Medical AG
May 22, 2026 Medtronic Harmony Delivery Catheter System Devices containing inner shaft assemblies from specific manufacturing lots may have an increased ... Class I Medtronic Heart Valves Division
May 22, 2026 Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected... Potential for thrombus formation during prolonged use of the introducer. Class I Abiomed, Inc.
May 22, 2026 Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set ... Potential for thrombus formation during prolonged use of the introducer. Class I Abiomed, Inc.
May 22, 2026 Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set ... Potential for thrombus formation during prolonged use of the introducer. Class I Abiomed, Inc.
May 22, 2026 Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected... Potential for thrombus formation during prolonged use of the introducer. Class I Abiomed, Inc.
May 21, 2026 Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Cata... There have been reports of air and medication leakage from the nebulizer cup during therapy of Vo... Class I Baxter Healthcare Corporation
May 21, 2026 Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catal... There have been reports of air and medication leakage from the nebulizer cup during therapy of Vo... Class I Baxter Healthcare Corporation
May 21, 2026 A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgica... Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the d... Class I Windstone Medical Packaging, Inc.
May 21, 2026 A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgi... Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the d... Class I Windstone Medical Packaging, Inc.
May 21, 2026 Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/... There have been reports of air and medication leakage from the nebulizer cup during therapy of Vo... Class I Baxter Healthcare Corporation
May 21, 2026 A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, ... Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the d... Class I Windstone Medical Packaging, Inc.
May 21, 2026 A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgi... Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the d... Class I Windstone Medical Packaging, Inc.
May 21, 2026 Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Ca... There have been reports of air and medication leakage from the nebulizer cup during therapy of Vo... Class I Baxter Healthcare Corporation
May 20, 2026 Omnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (... External soft cannula damage during manufacturing that results in insulin leaking around the Pod ... Class I Insulet Corporation

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.