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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

3,419 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,419 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 3,419 FDA device recalls in MA.

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DateProductReasonClassFirm
Oct 29, 2015 NxStage System One S Cycler (High Permeability Hemodialysis System) Model no... Ultrafiltration (UF) Volume software error inaccurate fluid removal Class II NxStage Medical, Inc.
Oct 23, 2015 Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For Use i... Dissolution units and replacement motors units do not provide full thermal protection for both th... Class II Fresenius Medical Care Renal Therapies Group, LLC
Oct 23, 2015 Fresenius Modified Mixer Motor (for 132 Gallon Dissolution Units), P/N 160075... Dissolution units and replacement motors units do not provide full thermal protection for both th... Class II Fresenius Medical Care Renal Therapies Group, LLC
Oct 23, 2015 Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147. For Use in the... Dissolution units and replacement motors units do not provide full thermal protection for both th... Class II Fresenius Medical Care Renal Therapies Group, LLC
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 40 cm, Model e1651-84. ... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68. In... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and ... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model ... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model ... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicat... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indi... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 14, 2015 Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M,... The following MRx software issue has been identified: MRx model M3535A with software version F.03... Class II Philips Electronics North America Corporation
Oct 1, 2015 Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura... Upon initiating Fluoroscopy the user may encounter a user message Fluoro failed. Class II Philips Electronics North America Corporation
Sep 17, 2015 Philips DuraDiagnost stationary X-ray system Buttons or keys on the monitor allow the user to turn the volume setting down to 0", in which ca... Class II Philips Electronics North America Corporation
Sep 14, 2015 Samsung GM60A-40S Intended for use in generating radiographic images of hu... When the system is driving over a non-conductive floor and then over a conductive, grounded part,... Class II NeuroLogica Corporation
Sep 10, 2015 Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 8.5 mm, Sterile ... Sterility of device is compromised due to breach in the packaging Class II Smith & Nephew, Inc., Endoscopy Div.
Sep 10, 2015 Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile ... Sterility of device is compromised due to breach in the packaging Class II Smith & Nephew, Inc., Endoscopy Div.
Sep 10, 2015 Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile ... Sterility of device is compromised due to breach in the packaging Class II Smith & Nephew, Inc., Endoscopy Div.
Sep 10, 2015 Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile ... Sterility of device is compromised due to breach in the packaging Class II Smith & Nephew, Inc., Endoscopy Div.
Sep 6, 2015 Philips Healthcare Ingenuity CT Computed Tomography X-Ray System Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series d... Class II Philips Healthcare
Sep 6, 2015 Philips Healthcare Ingenuity Core Computed Tomography X-Ray System Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series d... Class II Philips Healthcare
Sep 6, 2015 Philips Healthcare Ingenuity Core128 Computed Tomography X-Ray System Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series d... Class II Philips Healthcare
Sep 6, 2015 Philips Healthcare Ingenuity Elite Computed Tomography X-Ray System Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series d... Class II Philips Healthcare
Sep 6, 2015 Philips Healthcare Brilliance iCT SP Computed Tomography X-Ray System Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series d... Class II Philips Healthcare
Sep 6, 2015 Philips Healthcare Brilliance 64 Computed Tomography X-Ray System Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series d... Class II Philips Healthcare
Sep 6, 2015 Philips Healthcare Brilliance iCT Computed Tomography X-Ray System Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series d... Class II Philips Healthcare
Aug 31, 2015 ConFormis iDUO G2, Right Lateral Catalog Number: M5723INT0600240 (US) ... May contain small amounts of ethylene glycol residue Class II ConforMIS, Inc.
Aug 31, 2015 ConForMIS Unicondylar Knee Replacement System iUNI G2, Left Medial Catalog ... May contain small amounts of ethylene glycol residue Class II ConforMIS, Inc.
Aug 31, 2015 ConFormis iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT... May contain small amounts of ethylene glycol residue Class II ConforMIS, Inc.
Aug 31, 2015 ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, L... May contain small amounts of ethylene glycol residue Class II ConforMIS, Inc.
Aug 31, 2015 ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IP... May contain small amounts of ethylene glycol residue Class II ConforMIS, Inc.
Aug 31, 2015 ConForMIS iDuo Knee Bicompartmental Knee Replacement System , iDUO G2, Right ... May contain small amounts of ethylene glycol residue Class II ConforMIS, Inc.
Aug 31, 2015 ConForMIS iDuo Bicompartmental Knee Replacement System iDUO G2, Left Lateral... May contain small amounts of ethylene glycol residue Class II ConforMIS, Inc.
Aug 31, 2015 ConForMIS iUNI Unicondylar Knee Replacement System iUNI G2, Right Lateral ... May contain small amounts of ethylene glycol residue Class II ConforMIS, Inc.
Aug 31, 2015 ConForMIS iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial C... May contain small amounts of ethylene glycol residue Class II ConforMIS, Inc.
Aug 31, 2015 ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog ... May contain small amounts of ethylene glycol residue Class II ConforMIS, Inc.
Aug 31, 2015 ConForMIS iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral ... May contain small amounts of ethylene glycol residue Class II ConforMIS, Inc.
Aug 24, 2015 Siemens RAPIDPoint 500 Measurement Cartridge Lactate (250) tests Part Number... RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodiu... Class II Siemens Healthcare Diagnostics Inc
Aug 24, 2015 Siemens RAPIDPoint 500 Measurement Cartridge Lactate (400) tests Part Number... RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodiu... Class II Siemens Healthcare Diagnostics Inc
Aug 24, 2015 Terumo Custom Cardiovascular Procedure Kit X-Coated Adult Pak P/N: 73124 Te... Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performanc... Class II Terumo Cardiovascular Systems Corp
Aug 24, 2015 Siemens RAPIDPoint 500 Measurement Cartridge Lactate (100) tests Part Number... RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodiu... Class II Siemens Healthcare Diagnostics Inc
Aug 24, 2015 Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/... Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performanc... Class II Terumo Cardiovascular Systems Corp
Aug 24, 2015 Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack P/N: 74... Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performanc... Class II Terumo Cardiovascular Systems Corp
Aug 24, 2015 Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/... Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performanc... Class II Terumo Cardiovascular Systems Corp

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.