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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

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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

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Browse Device Recalls

3,089 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,089 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 3,089 FDA device recalls.

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DateProductReasonClassFirm
May 27, 2026 MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896 A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circ... Class II Medtronic MiniMed, Inc.
May 27, 2026 Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dex... Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction wer... Class II Dexcom, Inc.
May 21, 2026 MOSAIQ Oncology Information System Software may fail to load adapted baseline shift plan during treatment delivery when a communicat... Class II Elekta, Inc.
May 20, 2026 Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor... Due to an incomplete process of the component screw by a subcontractor which prevents the properl... Class II United Orthopedic Corp.
May 20, 2026 Brand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and ... Due to an incomplete process of the component screw by a subcontractor which prevents the properl... Class II United Orthopedic Corp.
May 20, 2026 Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PS... Due to an incomplete process of the component screw by a subcontractor which prevents the properl... Class II United Orthopedic Corp.
May 20, 2026 Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left ... Due to an incomplete process of the component screw by a subcontractor which prevents the properl... Class II United Orthopedic Corp.
May 14, 2026 Automated Impella Controller (AIC), for use with left heart support blood pum... Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction wi... Class I Abiomed, Inc.
May 13, 2026 SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix ... Intraoperative neuromonitoring device, due to a software issue, may experience loss or interrupti... Class II Alphatec Spine, Inc.
May 13, 2026 Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model... Due to 11 volt Backup Battery failures. Class II Thoratec LLC
May 13, 2026 Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVA... Due to 11 volt Backup Battery failures. Class II Thoratec LLC
May 13, 2026 Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Ca... Due to 11 volt Backup Battery failures. Class II Thoratec LLC
May 12, 2026 Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model... Software malfunction may occur during pacing capture threshold test of pacemaker resulting in pr... Class II Abbott Medical
May 11, 2026 Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Meta... Firm received a complaint with no clinical impact in which a posterior augment was found within t... Class II Zimmer, Inc.
May 11, 2026 Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory ... Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf ... Class II Inspire Medical Systems Inc.
May 8, 2026 TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibi... Due to manufacturing/design issue where the knob on the tracking array may loosen causing potenti... Class II Think Surgical, Inc.
May 7, 2026 3mensio Workstation (Vascular Fenestrated) software User measurement value reported by diagnostic bioimaging software intended to measure/visualize c... Class II PIE Medical Imaging B.V.
May 7, 2026 Brand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Co... Due to out-of-specification, or potential out-of-specification, levels of endotoxins Class II TELEFLEX LLC
May 6, 2026 LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005. Potential software anomaly that can cause the pump to report a false battery-health value (typica... Class I Fresenius Kabi USA, LLC
May 5, 2026 Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser. Software anomaly that causes a false display of error code 5018. Class II IPG Medical Corporation
May 4, 2026 SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS,... Natus has become aware of two complaints related to the SD LTM 64 PLUS where the EEG traces acqui... Class II Micromed S.p.A.
Apr 30, 2026 Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI ... Due to incorrect shelf-life expiration date. Class II Advanced Bionics, LLC
Apr 29, 2026 REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The... Due to software issues where does not handle combo assay results. The software may replace the f... Class II Beckman Coulter Biomedical GmbH
Apr 24, 2026 Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Nu... Due to unintentionally activated near infrared handheld camera when attempting to turn off illumi... Class II Intuitive Surgical, Inc.
Apr 24, 2026 GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - O... GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 moni... Class II GE Medical Systems Information Technologies Inc
Apr 24, 2026 GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV... GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 moni... Class II GE Medical Systems Information Technologies Inc
Apr 21, 2026 MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analys... Software in development inadvertently made available for customer use. Use of this software versi... Class II GE Medical Systems China Co., Ltd.
Apr 20, 2026 navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navif... Due to complaints received for the Image Management System regarding image/metadata discrepancy w... Class II Ventana Medical Systems, Inc.
Apr 20, 2026 Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 ... Due to a software coding issues for calculating the implant orientation diagram printout for the ... Class II Staar Surgical AG
Apr 16, 2026 Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Numbe... It was reported that plates 2 and 3 were marked as passed , although it appeared that QC had not... Class II The Binding Site Group, Ltd.
Apr 14, 2026 Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: D... A software defect in which a low-priority file I/O check blocks the higher-priority thread respon... Class II Dexcom, Inc.
Apr 14, 2026 Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dex... A software defect in which a low-priority file I/O check blocks the higher-priority thread respon... Class II Dexcom, Inc.
Apr 14, 2026 Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dex... A software defect in which a low-priority file I/O check blocks the higher-priority thread respon... Class II Dexcom, Inc.
Apr 13, 2026 Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Product Name: ... Due to incorrect incubation process being performed on product. Class II HF Acquisition Co LLC
Apr 13, 2026 Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: ... Due to incorrect incubation process being performed on product. Class II HF Acquisition Co LLC
Apr 8, 2026 Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software ... Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode,... Class II Medtronic Neuromodulation
Apr 6, 2026 The intended use is to be paired with a weapon for aiming purposes. Wilcox is notifying all customers who have purchased a product from the BOSS Xe family that a sof... Class II Wilcox Industries Corp.
Apr 2, 2026 Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgica... Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to break... Class II Intuitive Surgical, Inc.
Mar 30, 2026 Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl a... Ten complaints have been received identifying issues at the time of use related to the package se... Class II Zimmer, Inc.
Mar 27, 2026 AIDBAGs are first aid kits of convenience composed of individually labeled de... Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has b... Class I North American Rescue LLC.
Mar 26, 2026 Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command M... Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester). Class II Spacelabs Healthcare, Inc.
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 Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Ver... Potential for the batter to have a thermal-runway event during charging, resulting in smoke and o... Class II THERANICA BIOELECTRONICS LTD
Mar 23, 2026 Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery P... The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-... Class II Advanced Bionics, LLC
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 19, 2026 Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm a... Due to a design issue causing the incorrect engraved numbering on implant that could result in th... Class II United Orthopedic Corp.
Mar 19, 2026 Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm a... Due to a design issue causing the incorrect engraved numbering on implant that could result in th... Class II United Orthopedic Corp.
Mar 19, 2026 Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Nu... Due to broken connector which may result in a temporary interruption of prescribed cold therapy. Class II DJO, LLC
Mar 19, 2026 Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Model/Catalog Nu... Due to broken connector which may result in a temporary interruption of prescribed cold therapy. Class II DJO, LLC

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.