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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

638 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 638 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 638 FDA device recalls.

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DateProductReasonClassFirm
May 25, 2022 EkoSonic Kit 135cm, 12cm TZ The EkoSonic Endovascular Device is packaged a... Product may be mislabeled. Class II Boston Scientific Corporation
May 25, 2022 EkoSonic Kit 106cm, 12cm TZ The EkoSonic Endovascular Device is packaged a... Product may be mislabeled. Class II Boston Scientific Corporation
Mar 8, 2022 ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support Pouch seals may be open, compromising sterility. Class II Boston Scientific Corporation
Mar 8, 2022 ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy Pouch seals may be open, compromising sterility. Class II Boston Scientific Corporation
Mar 3, 2022 EXALT Model D Single-Use Duodenoscope (Box 2) UPN: M0054242CE1 Intended U... Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known... Class II Boston Scientific Corporation
Mar 3, 2022 EXALT Model D Single-Use Duodenoscope (Box 1) UPN:M0054242CE0 Intended Us... Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known... Class II Boston Scientific Corporation
Mar 3, 2022 EXALT Model D Single- Use Duodenoscope (Box 1) UPN: M00542420 Intended ... Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known... Class II Boston Scientific Corporation
Mar 3, 2022 EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421 Intended ... Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known... Class II Boston Scientific Corporation
Feb 24, 2022 SpaceOAR Vue System, UPN SV-1010 and SV-2101. Used to temporarily position t... Users need to be aware that embolism is a possible adverse event associated with hydrogel misplac... Class II Boston Scientific Corporation
Feb 24, 2022 SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to tempora... Users need to be aware that embolism is a possible adverse event associated with hydrogel misplac... Class II Boston Scientific Corporation
Dec 22, 2021 HYDRATOME RX 44-30MM/260CM Material Number: M00583050 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 49-30-260-035 Material Number: M00573020 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 49-30-450-035 Material Number: M00573030 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material N... Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 DREAMTOME 49-20MM/450CM Material Number: M00584020 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME REVOLUTION RX 39-20-450-025 Material Number: M00584250 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 39-20-260-025 Material Number: M00573080 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 HYDRATOME RX 44-30MM/450CM Material Number: M00583070 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 39-30-260-025 Material Number: M00573100 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 44-20-450-035 Material Number: M00573050 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 44-30-450-035 Material Number: M00573070 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 39-30-450-025 Material Number: M00573110 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 44-30-260-035 Material Number: M00573060 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00... Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 HYDRATOME RX 49-30MM/260CM Material Number: M00583010 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Num... Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 DREAMTOME 49-30MM/260CM Material Number: M00584010 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 HYDRATOME RX 44-20MM/260CM Material Number: M00583040 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 ... Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME REVOLUTION RX 39-30-260-025 Material Number: M00584260 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 DREAMTOME 44-30MM/450CM Material Number: M00584070 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 49-20-260-035 Material Number: M00573000 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 DREAMTOME 49-30MM/450CM Material Number: M00584030 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 DREAMTOME 49-20MM/260CM Material Number: M00584000 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 39-20-450-025 Material Number: M00573090 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 39-30-260-025 Material Number: M00573100 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 DREAMTOME 44-30MM/260CM Material Number: M00584050 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 HYDRATOME RX 49-20MM/260CM Material Number: M00583000 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 44-20-260-035 Material Number: M00573040 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 HYDRATOME RX 44-20MM/450CM Material Number: M00583060 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Nov 8, 2021 Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbe... Manufacturing instructions did not include the directions to not retest the pneumatic kit compone... Class II Boston Scientific Corporation
Oct 21, 2021 HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures... Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonge... Class II Boston Scientific Corporation
Oct 21, 2021 HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of stricture... Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonge... Class II Boston Scientific Corporation
Oct 21, 2021 HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of stricture... Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonge... Class II Boston Scientific Corporation
Oct 21, 2021 HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures... Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonge... Class II Boston Scientific Corporation
Oct 21, 2021 HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures... Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonge... Class II Boston Scientific Corporation
Oct 21, 2021 HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictur... Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonge... Class II Boston Scientific Corporation
Oct 21, 2021 HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictur... Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonge... Class II Boston Scientific Corporation
Oct 21, 2021 HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strict... Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonge... 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.