Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Safety Ratings 11,700+ NHTSA crash test ratings Investigations 5,300+ NHTSA defect investigations Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports Brand History Cross-category recall lookup by company
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents State Safety Dashboards Safety grades for all 50 U.S. states ZIP Safety Report Check any 5-digit ZIP across 9 datasets
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases
Blog

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

Public Health

Nursing Homes14,700 CMS rated facilities Environmental80,000+ hazardous sites & releases BlogGuides, news & safety insights

Browse Device Recalls

79 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 79 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 79 FDA device recalls.

Clear
DateProductReasonClassFirm
May 31, 2024 Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left hear... Nine (9) Impella CP pumps failed inspection and were inadvertently released. Class I Abiomed, Inc.
Dec 27, 2023 Impella catheters - Intravascular micro axial blood pumps that support a pati... IFU has been updated to include warnings about the risk of the inlet perforating through the myoc... Class I Abiomed, Inc.
Dec 27, 2023 Impella catheters - Intravascular micro axial blood pumps that support a pati... New warnings are being added to the Instructions for Use for all affected products to reduce the ... Class II Abiomed, Inc.
Dec 6, 2023 Impella Connect, software portal for online device management that allows cli... The following features have been disabled from the web-based portal because the FDA has not evalu... Class II Abiomed, Inc.
Nov 7, 2023 Abiomed KIT, 14 Fr Introducer, 13 & 25 cm, ABMD Part of Pump Set (0048-0024, ... Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... Class II Abiomed, Inc.
Nov 7, 2023 Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump... Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... Class II Abiomed, Inc.
Nov 7, 2023 Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introd... Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... Class II Abiomed, Inc.
Nov 7, 2023 Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are ... Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... Class II Abiomed, Inc.
Nov 7, 2023 Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introdu... Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... Class II Abiomed, Inc.
Nov 7, 2023 Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(... Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... Class II Abiomed, Inc.
Nov 7, 2023 Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introdu... Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... Class II Abiomed, Inc.
Nov 7, 2023 Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introdu... Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... Class II Abiomed, Inc.
Nov 7, 2023 Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(... Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... Class II Abiomed, Inc.
Nov 7, 2023 Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040,... Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... Class II Abiomed, Inc.
Oct 10, 2023 Automated Impella Controller (AIC), product number 0042-000-US with software ... Pump not detected as connected to controller due to software issue. Class II Abiomed, Inc.
Oct 10, 2023 Automated Impella Controller (AIC), product number 0042-040-US with software ... Pump not detected as connected to controller due to software issue. Class II Abiomed, Inc.
Jun 29, 2023 Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product ... A higher than expected rate of thrombus formation or deposition has been observed. The risk is f... Class I Abiomed, Inc.
Jun 14, 2023 Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Nu... There is a potential risk for unintentional interaction of the Impella motor housing with the dis... Class I Abiomed, Inc.
Jun 14, 2023 Impella CP intravascular micro axial blood pump, Product Number 0048-0032 There is a potential risk for unintentional interaction of the Impella motor housing with the dis... Class I Abiomed, Inc.
Jun 14, 2023 Impella 2.5 intravascular micro axial blood pump, Product Number 005042 There is a potential risk for unintentional interaction of the Impella motor housing with the dis... Class I Abiomed, Inc.
Jun 14, 2023 Impella CP with SmartAssist intravascular micro axial blood pump, Product Num... There is a potential risk for unintentional interaction of the Impella motor housing with the dis... Class I Abiomed, Inc.
Jun 14, 2023 Impella 5.0 intravascular micro axial blood pump, Product Number 005062 There is a potential risk for unintentional interaction of the Impella motor housing with the dis... Class I Abiomed, Inc.
Jun 14, 2023 Impella LD intravascular micro axial blood pump, Product Number 005082 There is a potential risk for unintentional interaction of the Impella motor housing with the dis... Class I Abiomed, Inc.
May 26, 2023 Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457 There was one complaint that the sidearm of the device detached during explant of a pump. When t... Class II Abiomed, Inc.
Apr 17, 2023 Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood p... The Impella 5.5 pump experienced a heightened complaint rate for purge leaks. Class I Abiomed, Inc.
Dec 14, 2021 OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. ... The firm has received complaints of the OXY-1 System Console experiencing a power interruption wh... Class I Abiomed, Inc.
Mar 1, 2021 Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0... Retrospective reporting for the release of Technical Bulletin IMP-2643 AIC Version 8.5 Software U... Class II Abiomed, Inc.
Sep 4, 2019 lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support b... This one pump shipped with incorrect pump programming, the initial production working version of ... Class II Abiomed, Inc.
Jan 17, 2011 Automated Impella Controller (AIC) with the below product descriptions and co... Retrospective submission for following issues identified: 1. Alarm failures, power-path faults,... Class I Abiomed, 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.