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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

3,494 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
Mar 27, 2026 Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010... Includes an incorrect screw seat interface. Class II Straumann USA LLC
Mar 27, 2026 Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous... Includes an incorrect screw seat interface. Class II Straumann USA LLC
Mar 24, 2026 Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR u... Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys ... Class II Foundation Medicine, Inc.
Mar 23, 2026 Brand Name: Genius" Review Station Product Name: Genius" Review Station Disp... It was identified that certain devices were being operated outside the validated and FDA-cleared ... Class II Hologic, Inc
Mar 23, 2026 Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13; The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (... Class II Gentuity, LLC
Mar 20, 2026 Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx) Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel art... Class II Foundation Medicine, Inc.
Mar 17, 2026 Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art... A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More spec... Class II Straumann USA LLC
Mar 17, 2026 Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: ... A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More spec... Class II Straumann USA LLC
Mar 13, 2026 LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare U... Customers reported observing unexpectedly elevated results when using certain third-party micro-c... Class II Magellan Diagnostics, Inc.
Mar 13, 2026 (1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test K... Customers reported observing unexpectedly elevated results when using certain third-party micro-c... Class II Magellan Diagnostics, Inc.
Mar 13, 2026 LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ ... Customers reported observing unexpectedly elevated results when using certain third-party micro-c... Class II Magellan Diagnostics, Inc.
Mar 12, 2026 Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7 Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula ... Class I Insulet Corporation
Mar 7, 2026 Philips Spectral CT on Rails. Model Number: 728334. Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the... Class II PHILIPS MEDICAL SYSTEMS
Feb 18, 2026 Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labe... Increased risk of purge leaks with Generation 1 purge cassettes. Class I Abiomed, Inc.
Feb 16, 2026 Automated Impella Controller (AIC), labeled as the following with correspondi... Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC... Class I Abiomed, Inc.
Feb 10, 2026 EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner ... Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on ... Class II Boston Scientific Corporation
Feb 4, 2026 The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number... Potential for the Cassette Loading Lever to break. Class II Fresenius Kabi USA, LLC
Jan 27, 2026 Impella RP. Product Code: 0046-0011. Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to... Class I Abiomed, Inc.
Jan 27, 2026 Impella RP with SmartAssist. Product Code: 0046-0035. Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to... Class I Abiomed, Inc.
Jan 27, 2026 Impella RP Flex with SmartAssist. Product Code: 1000323. Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to... Class I Abiomed, Inc.
Jan 20, 2026 GEM Premier 5000 PAK; Part No. 00055407504. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... Class II Instrumentation Laboratory
Jan 20, 2026 GEM Premier 5000; Part No. 00055445010 & 00055445011. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... Class II Instrumentation Laboratory
Jan 20, 2026 GEM Premier 5000 PAK; Part No. 00055415004. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... Class II Instrumentation Laboratory
Jan 20, 2026 GEM Premier 5000 PAK; Part No. 00055360010. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... Class II Instrumentation Laboratory
Jan 20, 2026 GEM Premier 5000; Part No. 00055430011. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... Class II Instrumentation Laboratory
Jan 20, 2026 GEM Premier 5000; Part No: 00055415011. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... Class II Instrumentation Laboratory
Jan 20, 2026 GEM Premier 5000; Part No. 00055430004. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... Class II Instrumentation Laboratory
Jan 20, 2026 GEM Premier 5000; Part No. 00055415010. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... Class II Instrumentation Laboratory
Jan 20, 2026 GEM Premier 5000; Part No. 00055445004. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... Class II Instrumentation Laboratory
Jan 20, 2026 GEM Premier 5000 PAK; Part No. 00055360008. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... Class II Instrumentation Laboratory
Jan 20, 2026 GEM Premier 5000 PAK; Part No. 00055407510. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... Class II Instrumentation Laboratory
Jan 20, 2026 GEM Premier 5000; Part No. 00055445008. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... Class II Instrumentation Laboratory
Jan 20, 2026 GEM Premier 5000 PAK; Part No. 00055407508. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... Class II Instrumentation Laboratory
Jan 20, 2026 GEM Premier 5000 PAK; Part No. 00055360011. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... Class II Instrumentation Laboratory
Jan 20, 2026 GEM Premier 5000 PAK; Part No. 00055407511. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... Class II Instrumentation Laboratory
Jan 20, 2026 GEM Premier 5000; Part No. 00055415008. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... Class II Instrumentation Laboratory
Jan 20, 2026 GEM Premier 5000; Part No. 00055430008. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... Class II Instrumentation Laboratory
Jan 20, 2026 GEM Premier 5000; Model No. 00055430010. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... Class II Instrumentation Laboratory
Jan 20, 2026 GEM Premier 5000; Part No. 00055415005. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... Class II Instrumentation Laboratory
Jan 20, 2026 GEM Premier 5000 PAK, Part No. 00055360004. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... Class II Instrumentation Laboratory
Jan 9, 2026 FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 5... It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X... Class II FUJIFILM Healthcare Americas Corporation
Jan 7, 2026 Spectral CT 7500 on Rails; Product Code (REF): 728334; As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to... Class II Philips North America Llc
Jan 7, 2026 IQon Spectral CT; Product Code (REF): 728332; As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to... Class II Philips North America Llc
Jan 7, 2026 Spectral CT; Product Code (REF): 728333; As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to... Class II Philips North America Llc
Jan 7, 2026 Brilliance iCT; Product Code (REF): 728306; As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to... Class II Philips North America Llc
Jan 6, 2026 WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM The mix up of the impression caps provided in the package. The provided impression caps are magen... Class III Straumann USA LLC
Dec 31, 2025 Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit. A systematic positive bias of up to 20% was identified across the reportable potassium range, res... Class II Medica Corporation
Dec 31, 2025 BEAR Implant. Model Number: 1000. Incorrect expiration date on label that extends beyond the product's documented/approved shelf li... Class II Miach Orthopaedics
Dec 22, 2025 Patient Information Center iX; Software Version Number: 4.5.0 A recent software (SW) patch modifies Mobile Event Notification filter settings without providing... Class II Philips North America
Dec 19, 2025 AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Materia... Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... Class I 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.