Browse Device Recalls

3,235 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,235 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 3,235 FDA device recalls.

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DateProductReasonClassFirm
May 8, 2017 Merge PACS software. The firm name on the label is Merge Healthcare, Hartlan... Merge PACS did not show unviewed images when the last view was skipped. There is a potential risk... Class II Merge Healthcare, Inc.
May 8, 2017 Merge PACS software. Merge PACS (Picture Archiving Communication System) is... When cut lines are shown on an image, the lines may go from being vertical and then shift to hori... Class II Merge Healthcare, Inc.
Apr 26, 2017 enGen Track System with TCAutomation Software Version 4.2 A software anomaly with TCA Software V4.2 may potentially cause a delay in reporting of results d... Class II Ortho-Clinical Diagnostics
Apr 13, 2017 CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an elec... Software bug which allows parameters to be changed unintentionally during use. Class II CardioTek BV
Apr 10, 2017 RAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional use in... Potential Patient Demographic Error with Blank Patient ID Field Class II Siemens Healthcare Diagnostics Inc
Apr 3, 2017 AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1 ... Beckman Coulter has confirmed that the Export feature located in the Results area of the AQUIOS S... Class II Beckman Coulter Inc.
Mar 31, 2017 da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument; PN 480299-03; and ... Intuitive Surgical has become aware that in specific scenarios with system software P6 and the da... Class II Intuitive Surgical, Inc.
Mar 30, 2017 HeartMate¿ II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PC... St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with ne... Class I Thoratec Corporation
Mar 30, 2017 HeartMate¿ II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER,... St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with ne... Class I Thoratec Corporation
Mar 30, 2017 HeartMate¿ II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL... St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with ne... Class I Thoratec Corporation
Mar 30, 2017 18L6 HD transducer on the ACUSON S Family ultrasound systems with software ve... When scanning with the 18L6 HD transducer on the ACUSON HELX" Evolution with Touch Control, the u... Class II Siemens Medical Solutions USA, Inc.
Mar 28, 2017 Artis zee, Angiographic x-ray system Software error - As a result of a software fault in Artis zee systems with software version VD11 ... Class II Siemens Medical Solutions USA, Inc
Mar 21, 2017 Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular ... Due to a design change in 2015, corrosion on the sample probe electrical contacts can occur and l... Class II Roche Diagnostics Corporation
Mar 14, 2017 NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS Sys... Software defect: the NBS software may accidentally generate duplicate copies of one or several fi... Class II Nexstim PLC
Mar 14, 2017 Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigat... Software defect: the NBS software may accidentally generate duplicate copies of one or several fi... Class II Nexstim PLC
Mar 13, 2017 Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1,... Rare isolates of Enterobacteriaceae may generate a susceptible meropenem Minimum Inhibitory Conce... Class II Accelerate Diagnostics Inc
Mar 8, 2017 enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software ... Software anomaly; Thermo-Fisher Scientific initially discovered and Ortho-Clinical Diagnostics, s... Class II Ortho-Clinical Diagnostics
Mar 7, 2017 Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory... Potential for errors in patient results generated by the Specimen Gate Laboratory Software. Class II PerkinElmer Life and Analytical Sciences, Walla...
Mar 6, 2017 Syngo.via, Picture archiving and communication system Syngo via is a softwar... Software changes now available to address several issues Class II Siemens Medical Solutions USA, Inc
Mar 6, 2017 Syngo.x, Picture archiving and communication system Syngo via is a software ... Software changes now available to address several issues Class II Siemens Medical Solutions USA, Inc
Mar 2, 2017 eCare Coordinator Product Usage: is software intended for use in data ag... eCareCoordinator (eCC) is intended for use in data aggregation, patient interaction facilitation,... Class II Philips Visicu
Mar 2, 2017 Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254. Product Usage: VMA so... Ortho Kinematics notified customers that errors were contained in Radiological Read Report and VM... Class II Ortho Kinematics, Inc
Mar 1, 2017 Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx Roche Diagnostics Corp. initiated a voluntary correction because a rack crash may occur on the Co... Class II Roche Diagnostics Corporation
Mar 1, 2017 Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx "Roche Diagnostics Corp. initiated a voluntary correction because a rack crash may occur on the C... Class II Roche Diagnostics Corporation
Feb 27, 2017 Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR) Liebel-Flarsheim... Software issue. The difference between the display and dosimeter readings In the Child/Pediatric... Class II LIEBEL-FLARSHEIM COMPANY LLC
Feb 27, 2017 Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim ur... Software issue. The difference between the display and dosimeter readings In the Child/Pediatric... Class II LIEBEL-FLARSHEIM COMPANY LLC
Feb 27, 2017 MEDTECH ROSA Spine 1.0.2 The device is intended for the spatial positioning ... Unapproved change made by the supplier. Class II Zimmer Biomet, Inc.
Feb 23, 2017 Brilliance BigBore Radiology CT - 728244 Computed Tomography X-ray systems i... Philips identified a 4D CT pulmonary phase issue on Brilliance BigBore Oncology/Radiology CT with... Class II Philips Medical Systems (Cleveland) Inc
Feb 20, 2017 Syngo.plaza, Picture Archiving and Communications System (PACS) Syngo.plaza ... Software updates Class II Siemens Medical Solutions USA, Inc
Feb 15, 2017 Prismaflex Control Unit. Dialyzer, high permeability with or without sealed ... Firm has received reports of device operators failing to adhere to instructions for use pertainin... Class II Baxter Healthcare Corporation
Feb 14, 2017 ARTISTE" MV System Software update Class II Siemens Medical Solutions USA, Inc
Feb 14, 2017 Mevatron M2/Primus Mid-Energy PRIMUS HI Software update Class II Siemens Medical Solutions USA, Inc
Feb 14, 2017 ONCOR" Expression ONCOR" Impression ONCOR" Impression plus Software update Class II Siemens Medical Solutions USA, Inc
Feb 14, 2017 ONCOR" Avant-garde Software update Class II Siemens Medical Solutions USA, Inc
Feb 2, 2017 ADVIA Centaur XPT System Software Versions V1.0.1, V1.0.2, V1.0.3, V1.1 and V... Multiple software issues, which may affect the operation and workflow of the system. Potential fo... Class II Siemens Healthcare Diagnostics, Inc.
Feb 1, 2017 Final Fit Software Version 1.11 and 1.12; PC Based software installed outsi... During treatment planning, the procedure was programmed with an unintended (wrong) correction. Class II Nidek Inc
Feb 1, 2017 Philips V60 Ventilator with Version 2.20 Software, Description: V 60 Ven... The V60 Ventilator with Version 2.20 software installed may falsely detect that the blower motor ... Class II Respironics California Inc
Jan 31, 2017 MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and bel... Medtronic has identified a software anomaly that can prevent the internal battery of the pump fro... Class II Medtronic Inc.
Jan 26, 2017 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product... SIGMA Spectrum Infusion Pumps with Master Drug Library, Software V8.00.02 contains an anomaly tha... Class II Baxter Healthcare Corporation
Jan 23, 2017 Merge LIS A defect in the software resulted in medications that are not associated with the patient (i.e., ... Class II Merge Healthcare, Inc.
Jan 18, 2017 Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation ... An error in NVIDIA GPU (Graphics Processing Unit) card drivers can occur for certain software pro... Class II RAYSEARCH LABORATORIES AB
Jan 14, 2017 MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated B... Indications for use are not cleared or approved for market in the U.S. Class II Med-Hot Thermal Imaging, Inc.
Jan 11, 2017 Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quanti... Ortho Kinematics Inc. sent a Notice of Correction to Released Testing Results, Radiological Read ... Class II Ortho Kinematics, Inc
Jan 11, 2017 VIDAS 3 software v. 1.1.4 During development of the VIDAS 3 software version 1.2, some anomalies have been identified and o... Class II BioMerieux SA
Jan 11, 2017 Syngo.plaza, picture archiving and communications system. Software update for improvements and to resolve several issues Class II Siemens Medical Solutions USA, Inc
Jan 11, 2017 Mammomat Inspiration full, field digital,system,x-ray,mammographic Product... Software error Class II Siemens Medical Solutions USA, Inc
Jan 5, 2017 EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra O... There is a possibility for data to be stored under the wrong patient on the DICOM Server followin... Class II Haag-Streit USA Inc
Dec 30, 2016 Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable ... Depleted Battery alarm shows instead of Replace Battery. On battery power, ongoing therapy stops,... Class II Hospira Inc., A Pfizer Company
Dec 23, 2016 Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiati... Cross profile for Varian 60 degree wedge shows "horns." Class II Elekta, Inc.
Dec 22, 2016 IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database an... A customer experienced when using IMPAX CV Reporting software, specifically, when building a NIV ... Class II AGFA Healthcare Corp.

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.