Browse Device Recalls

2,945 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,945 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 2,945 FDA device recalls.

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DateProductReasonClassFirm
Oct 21, 2025 CareLink Clinic, REF: MMT-7350 Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Grap... Class II Medtronic MiniMed, Inc.
Oct 17, 2025 IntelePACS - InteleConnect / TechPortal Software application that receives digital images and data to be communicated, processed, manipul... Class II INTELERAD MEDICAL SYSTEMS INCORPORATED
Oct 13, 2025 DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Softwar... Potential for device to not meet specifications resulting in incorrect results or delay of referr... Class II DERMASENSOR INC
Oct 9, 2025 Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Numbe... Due to issues with the system's stereotactic radiosurgery (SRS) treatment cannot be guaranteed fo... Class II C-RAD POSITIONING AB
Oct 9, 2025 Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVA... Due to potential corrosion issues associated with the Backup Battery cable connector that may cau... Class II Thoratec LLC
Oct 9, 2025 Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Ca... Due to potential corrosion issues associated with the Backup Battery cable connector that may cau... Class II Thoratec LLC
Oct 9, 2025 Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) M... Due to potential corrosion issues associated with the Backup Battery cable connector that may cau... Class II Thoratec LLC
Oct 9, 2025 Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Mod... Due to potential corrosion issues associated with the Backup Battery cable connector that may cau... Class II Thoratec LLC
Oct 8, 2025 Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CAT... Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility... Class II Sterilmed, Inc.
Oct 8, 2025 Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WIT... Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility... Class II Sterilmed, Inc.
Oct 6, 2025 Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are batt... Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or ma... Class I Tandem Diabetes Care, Inc.
Oct 1, 2025 Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immu... Due to distributing the measles IgG IVD without a premarket approved/cleared. Class II Quest International, Inc.
Sep 30, 2025 Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereo... Due to increased risk that paint flakes from the engravings may separate from the device and ther... Class II Elekta, Inc.
Sep 30, 2025 Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET F... The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damag... Class I B BRAUN MEDICAL INC
Sep 26, 2025 Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model... Printer Support Module (PSM) may be subject to insufficient soldering, which may cause loosening ... Class II Medistim Asa
Sep 25, 2025 Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Ve... Issue 1: The potential for unintentional continued gantry/couch movement when a specific button s... Class II PHILIPS MEDICAL SYSTEMS
Sep 25, 2025 Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast ... Due to an identified manufacturing defect involving coating material lifting within the catheter'... Class I BALT USA, LLC
Sep 25, 2025 Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.... Issue 1: The potential for unintentional continued gantry/couch movement when a specific button s... Class II PHILIPS MEDICAL SYSTEMS
Sep 25, 2025 Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Ver... Issue 1: The potential for unintentional continued gantry/couch movement when a specific button s... Class II PHILIPS MEDICAL SYSTEMS
Sep 24, 2025 Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/C... It was determined there is the potential of silicone fragments detaching from the yellow sealing ... Class II Aesculap Inc
Sep 24, 2025 Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Ca... It was determined there is the potential of silicone fragments detaching from the yellow sealing ... Class II Aesculap Inc
Sep 24, 2025 Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/... It was determined there is the potential of silicone fragments detaching from the yellow sealing ... Class II Aesculap Inc
Sep 24, 2025 Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER ... It was determined there is the potential of silicone fragments detaching from the yellow sealing ... Class II Aesculap Inc
Sep 23, 2025 BD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), C... Product service credentials used by some BD technical support teams to access certain BD products... Class II Becton Dickinson & Co.
Sep 22, 2025 DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 T... Due to a software error code that crashes during acquisition on patient sample when running custo... Class II Beckman Coulter Inc.
Sep 19, 2025 DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part N... Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the ... Class II Beckman Coulter, Inc.
Sep 19, 2025 DxI 9000 Access Immunoassay Analyzer, Part Number C11137 Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the ... Class II Beckman Coulter, Inc.
Sep 19, 2025 Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27... Complaint identified issue with AI surgical planning software that may result in implant malalig... Class II Kico Knee Innovation Company
Sep 18, 2025 LOGIQ P10 series with software version R4.5.7 Model Number 5877534 The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values... Class II GE Medical Systems, LLC
Sep 18, 2025 LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model N... The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values... Class II GE Medical Systems, LLC
Sep 18, 2025 Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Cat... Software issue for hq analyzer results in system not visibly applying appropriate flagging to res... Class II Abbott Laboratories
Sep 18, 2025 LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Mod... The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values... Class II GE Medical Systems, LLC
Sep 17, 2025 MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.... When appending a care plan that contains one or more wave medication orders, the occurrence and ... Class II ELEKTA SOLUTIONS AB
Sep 16, 2025 SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP)... A software anomaly, under specific conditions when large rotational alignment values are applied ... Class II Surgical Theater Inc
Sep 16, 2025 Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 9... Due to two distinct issues: 1. During patient admission, patient demographic fields may default ... Class II Spacelabs Healthcare, Ltd.
Sep 16, 2025 Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software ... A software anomaly, under specific conditions when large rotational alignment values are applied ... Class II Surgical Theater Inc
Sep 16, 2025 Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, im... A software anomaly, under specific conditions when large rotational alignment values are applied ... Class II Surgical Theater Inc
Sep 16, 2025 SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP... A software anomaly, under specific conditions when large rotational alignment values are applied ... Class II Surgical Theater Inc
Sep 16, 2025 Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), sof... A software anomaly, under specific conditions when large rotational alignment values are applied ... Class II Surgical Theater Inc
Sep 16, 2025 Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmente... A software anomaly, under specific conditions when large rotational alignment values are applied ... Class II Surgical Theater Inc
Sep 16, 2025 SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radio... A software anomaly, under specific conditions when large rotational alignment values are applied ... Class II Surgical Theater Inc
Sep 9, 2025 Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 ... The device either indicated a failure of the piston ventilator before use or suffered a failure o... Class I Draeger, Inc.
Sep 9, 2025 Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 S... The device either indicated a failure of the piston ventilator before use or suffered a failure o... Class I Draeger, Inc.
Sep 9, 2025 Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build ... Potential that the measured value may be smaller than the actual area. Class II MedicalCommunications GmbH
Sep 8, 2025 CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122... Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis d... Class II Beckman Coulter, Inc.
Sep 5, 2025 Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm ... Due to products that have not completed design updates and performance testing being released/dis... Class II Exactech, Inc.
Sep 5, 2025 Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter M... Due to products that have not completed design updates and performance testing being released/dis... Class II Exactech, Inc.
Sep 5, 2025 Brand Name: Branding is not applied to this product. Product Name: DVI displ... Due to display cables used for monitors were not in compliance with electromagnetic interference ... Class II Spacelabs Healthcare, Inc.
Sep 5, 2025 Brand Name: Branding is not applied to this product. Product Name: DVI displ... Due to display cables used for monitors were not in compliance with electromagnetic interference ... Class II Spacelabs Healthcare, Inc.
Sep 5, 2025 GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with softwar... GE HealthCare has identified an issue affecting Carescape" Central Station (CSCS) with software v... Class II Wipro GE Healthcare Private Ltd.

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.