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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

3,494 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,494 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 3,494 FDA device recalls in MA.

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DateProductReasonClassFirm
Jul 22, 2026 FUJIFILM Synapse PACS software v7.4.310; radiological image processing system Software issue may cause the ruler measurement to be inaccurate. Class II FUJIFILM Healthcare Americas Corporation
Jul 20, 2026 Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF#... Due to a firmware defect, the portable organ transfer device datalogger may lose its configuratio... Class II Paragonix Technologies Inc.
Jul 16, 2026 Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxoli... Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently con... Class II Straumann USA LLC
Jul 14, 2026 Suture Cinch Long 1pk. Endoscopic tissue approximation device. Device may fail to deploy the cinch implant and/or fail to cut the suture as intended. Class II Boston Scientific Corporation
Jul 14, 2026 OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device. Device may fail to deploy the cinch implant and/or fail to cut the suture as intended. Class II Boston Scientific Corporation
Jul 13, 2026 Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine As... Class II Siemens Healthcare Diagnostics, Inc.
Jul 13, 2026 Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x ... Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine As... Class II Siemens Healthcare Diagnostics, Inc.
Jul 13, 2026 OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Sm... There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which... Class II OBP Medical Corporation
Jul 13, 2026 GM Helix Implant, Endosseous Dental Implant Article No. 109.984 There may be a mismatch between the implant contained inside the packaging and the information de... Class II Straumann USA LLC
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
Jul 1, 2026 Cardiac Workstation 7000. Product Number: 860441. Device will intermittently provide inaccurate data related to native heart rate. Class II Philips North America Llc
Jul 1, 2026 Cardiac Workstation 5000. Product Number: 860439. Device will intermittently provide inaccurate data related to native heart rate. Class II Philips North America Llc
Jun 30, 2026 Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: ... Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow... Class II Fresenius Medical Care Renal Therapies Group, LLC
Jun 30, 2026 Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions... Potential for breach in sterile barrier of device packaging. Class II Boston Scientific Corporation
Jun 30, 2026 Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions an... Potential for breach in sterile barrier of device packaging. Class II Boston Scientific Corporation
Jun 30, 2026 Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: ... Potential for breach in sterile barrier of device packaging. Class II Boston Scientific Corporation
Jun 30, 2026 Rapid Refill Continuous Injection System, UPN M00566001 Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There ... Class II Boston Scientific Corporation
Jun 26, 2026 Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 1044539... out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant C... Class III Siemens Healthcare Diagnostics, Inc.
Jun 11, 2026 Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity P... The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to ... Class II PHILIPS MEDICAL SYSTEMS
Jun 11, 2026 Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64... The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to ... Class II PHILIPS MEDICAL SYSTEMS
Jun 11, 2026 IQon Spectral CT IQon Spectral CT Upgrades The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to ... Class II PHILIPS MEDICAL SYSTEMS
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 Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0... Software issue that can cause an increase in spontaneous software closures. Class II Foundation Medicine, Inc.
Jun 5, 2026 Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the fo... Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device c... Class II Philips North America Llc
May 26, 2026 Philips Avalon Fetal Monitor, FM 30 Part numberM2703A Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulle... Class II Philips North America Llc
May 26, 2026 Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulle... Class II Philips North America Llc
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 GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 000... The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with ... Class II Instrumentation Laboratory
May 21, 2026 GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 000554075... The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots ... Class II Instrumentation Laboratory
May 21, 2026 CRE Pro Wireguided 18-20mm 240cm Potential sterile breach of the pouches in which devices are packaged. Class II Boston Scientific Corporation
May 21, 2026 CRE Wireguided 10-12mm 240cm Potential sterile breach of the pouches in which devices are packaged. Class II Boston Scientific Corporation
May 21, 2026 CRE Pro Wireguided 8-10mm 240cm Potential sterile breach of the pouches in which devices are packaged. Class II Boston Scientific Corporation
May 21, 2026 CRE Wireguided 18-20mm 240cm Potential sterile breach of the pouches in which devices are packaged. Class II Boston Scientific Corporation
May 21, 2026 CRE Wireguided 6-8mm 240cm Potential sterile breach of the pouches in which devices are packaged. Class II Boston Scientific Corporation
May 21, 2026 CRE Wireguided 15-18mm 240cm Potential sterile breach of the pouches in which devices are packaged. Class II Boston Scientific 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.