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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

2,260 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,260 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 2,260 FDA device recalls in 2021.

Clear
DateProductReasonClassFirm
Mar 3, 2021 p-Chip Wand Reader The laser operation might fall under a higher laser class. Class II p-Chip Corporation
Mar 2, 2021 Assure COVID-19 IgG/IgM Rapid Test Device that include: 1) Pouch Label - Fa... Due to Products being incorrect labeling "for diagnostic use" and labelled with an unsupported 24... Class II AZURE BIOTECH INC
Mar 2, 2021 Synapse PACS - Radiological Image Processing System - Product Usage: intended... The wrong patient information may be displayed in the viewer or PowerJacket. Class II Fujifilm Medical Systems U.S.A., Inc.
Mar 2, 2021 Consist of a distal connection mechanism (either standard Terumo Ball Quick C... There is a potential for the stainless steel locking plates on the device's sternal retractor loc... Class II Terumo Cardiovascular Systems Corporation
Mar 2, 2021 BCS XP System: Multipurpose system for in vitro coagulation studies. Product ... Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected... Class II Siemens Healthcare Diagnostics, Inc.
Mar 1, 2021 ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System). In case of a failed automatic marker detection, a software error causes parts of the display to ... Class II Brainlab AG
Mar 1, 2021 MyWay Walker Chassis - Product Usage: is intended for use by children already... Due to a failure of the welds, the casters detached from the rear legs of the walker. Class II James Leckey Design Ltd
Mar 1, 2021 Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by... Arietta 850 software version 4.0.0., 4.0.1, and 4.0.2 has an error in the focus point and transdu... Class II Hitachi Medical Systems America 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.
Mar 1, 2021 Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "... The kit does not have an emergency use authorization (EUA). Class II Cellex
Feb 26, 2021 Medtronic, REF: MMT-7008D, Enlite Glucose Sensor for the following packaging:... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020C1 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7008B, Enlite Glucose Sensor for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic, REF: MMT-7008A, Enlite Glucose Sensor for the following packaging:... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neopla... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020C2 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable,... Erroneously high FeNO levels which may contribute to premature discontinuation of effective asthm... Class II CAIRE DIAGNOSTICS INC
Feb 26, 2021 Medtronic REF: MMT-7020C5 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020D5 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020LA, Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - ... There is a potential for tube trays to leak which could potentially result in false positive res... Class II Hologic, Inc
Feb 26, 2021 Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanie... Medtronic HeartWare HVAD System Instructions for Use (IFU) and Patient Manual (PM) updates regard... Class I Heartware, Inc.
Feb 26, 2021 Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, M... Their is a potential that Video Processor/Illuminators may exhibit flickering, loss of image or u... Class II Stryker Corporation
Feb 26, 2021 Medtronic REF: MMT-7020C4 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US... There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cable... Class I Heartware, Inc.
Feb 26, 2021 Medtronic REF: MMT-7020LB, Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) ... There is a potential for the hemostatic valve to dislodge while introducing the dilator or device... Class II Biosense Webster, Inc.
Feb 26, 2021 Medtronic REF: MMT-7020GA, Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic HVAD Alarm Adapter, Product Number: 1450 There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cable... Class I Heartware, Inc.
Feb 26, 2021 Power Supply: 1. Medtronic HVAD Controller AC Adapter, Product Numbers: 142... There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cable... Class I Heartware, Inc.
Feb 26, 2021 Medtronic REF: MMT-7020D4 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic, REF: MMT-7008C, Enlite Glucose Sensor for the following packaging:... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended t... The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration... Class II Covidien Llc
Feb 26, 2021 Medtronic REF: MMT-7020D3 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to... The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration... Class II Covidien Llc
Feb 26, 2021 Medtronic HVAD Monitor Data Cable, Product Number: 1575 There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cable... Class I Heartware, Inc.
Feb 26, 2021 Medtronic REF: MMT-7020D1 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Interventional Fluoroscopic X-Ray System - Product Usage: developed for singl... Siemens has become aware of a potential issue in which the imaging system UPS sporadically forces... Class II Siemens Medical Solutions USA, Inc
Feb 26, 2021 Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C... There is a potential for the hemostatic valve to dislodge while introducing the dilator or device... Class II Biosense Webster, Inc.
Feb 26, 2021 Medtronic REF: MMT-7020A, Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cable... Class I Heartware, Inc.
Feb 26, 2021 Medtronic REF: MMT-7020C3 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020D2 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020B, Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401... There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cable... Class I Heartware, Inc.
Feb 26, 2021 Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an... Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump mo... Class I STEP-HAR MEDICAL LLC
Feb 26, 2021 Medtronic REF: MMT-7020C Guardian Sensor (3) kit for the following packaging:... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanie... IFU and Patient Manual updated to describe Expected Alarm Duration. The Instructions for Use (IF... Class II Heartware, Inc.
Feb 26, 2021 CyberKnife Treatment Delivery System - Product Usage: indicated for image-gui... The set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen... Class II Accuray Incorporated
Feb 26, 2021 Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C... There is a potential for the hemostatic valve to dislodge while introducing the dilator or device... Class II Biosense Webster, Inc.
Feb 26, 2021 Instructions for Use and Patient Manual for HeartWare HVAD System. Accompani... IFU and Patient Manual updated to describe HVAD Controller Connection Verification. The labeling ... Class II Heartware, 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.