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
Oct 14, 2021 Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0 When the ultrasound system is used in combination with a Fujifilm (formally Hitachi) transducer, ... Class II FujiFilm Healthcare Americas Corporation
Oct 14, 2021 Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3 Diagnostic ultrasound system with the specified software version and used in conjunction with a F... Class II FujiFilm Healthcare Americas Corporation
Oct 14, 2021 Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3 Diagnostic ultrasound system with the specified software version and used in conjunction with a F... Class II FujiFilm Healthcare Americas Corporation
Oct 14, 2021 Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3 Diagnostic ultrasound system with the specified software version and used in conjunction with a F... Class II FujiFilm Healthcare Americas Corporation
Oct 12, 2021 Medtronic CareLink SmartSync Device Manager application software (D00U005) us... The processing of collected episode data may fail due to a software error. Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Oct 12, 2021 Artis icono floor with software VE20C-diagnostic imaging angiography system ... Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. U... Class II Siemens Medical Solutions USA, Inc
Oct 12, 2021 Artis icono biplane with software VE20C-diagnostic imaging angiography system... Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. U... Class II Siemens Medical Solutions USA, Inc
Oct 12, 2021 Artis pheno with software VE20C- diagnostic imaging angiography system Mode... Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. U... Class II Siemens Medical Solutions USA, Inc
Oct 5, 2021 Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10... System operator manual states that the system should be rebooted once, every 7 days. In some case... Class II Siemens Medical Solutions USA, Inc
Oct 4, 2021 Cliquid MD version 3.4 software used in conjunction with Analyst MD software ... The values of the Internal Standard (IS) concentrations are incorrectly derived when the user bui... Class II AB SCIEX
Sep 29, 2021 ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF ... Twelve software-related issues affecting software version 9.41 and earlier were identified. The i... Class II Abbott Laboratories
Sep 29, 2021 ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/... Twelve software-related issues affecting software version 9.41 and earlier were identified. The i... Class II Abbott Laboratories
Sep 29, 2021 Hemodialysis Delivery System, Software Version 2.x. If the operator initiates therapy with a saved prescription profile and makes a change to the pr... Class II Baxter Healthcare Corporation
Sep 24, 2021 Philips Azurion systems with software releases 2.1(L1) and 2.1(L2) 3D-RA is a reconstruction software product that can be used with the Philips Azurin system. This ... Class II Philips Healthcare
Sep 24, 2021 Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 i... Software error, the software can produce an incorrect interpretation of the table rotation if the... Class II Siemens Medical Solutions USA, Inc
Sep 24, 2021 Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.... When the user presses or releases both the APC (accept) button and the Float Tabletop (panning) b... Class II Philips North America Llc
Sep 23, 2021 Clinician Programmer Application (CPA) model A610 Clinician Software Application A software anomaly may occur with the clinician programmer application. Class II Medtronic Neuromodulation
Sep 22, 2021 da Vinci SP Surgical systems with the following Model Name/ Model Number / UD... Issue was identified during internal engineering evaluation. Use of the system with the affected ... Class II Intuitive Surgical, Inc.
Sep 22, 2021 ROSA One 3.1 Brain application The device is intended for the spatial posi... The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which le... Class I MEDTECH SAS
Sep 21, 2021 EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232 Ultrasound system software issue can cause an EchoNavigator error notification, leading to an unr... Class II Philips Ultrasound Inc
Sep 10, 2021 Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ... Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Venti... Class II Draeger Medical, Inc.
Sep 10, 2021 Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for t... Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Venti... Class II Draeger Medical, Inc.
Aug 31, 2021 Medtronic sterile single-use blades that are components of the StraightShot M... There was an increase in complaints related to tip breaks and wobble/vibration. Class II Medtronic Xomed, Inc.
Aug 31, 2021 Medtronic sterile single-use blades that are components of the StraightShot M... There was an increase in complaints related to tip breaks and wobble/vibration. Class II Medtronic Xomed, Inc.
Aug 31, 2021 Medtronic Sterile single-use blades that are components of the StraightShot M... There was an increase in complaints related to tip breaks and wobble/vibration. Class II Medtronic Xomed, Inc.
Aug 30, 2021 SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000 software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1... Class II Siemens Medical Solutions USA, Inc
Aug 30, 2021 SOMATOM Drive with software syngo.CT VB20 Model #10431700 software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1... Class II Siemens Medical Solutions USA, Inc
Aug 30, 2021 SOMATOM Confidence with software syngo.CT VB20 Model #10590100 software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1... Class II Siemens Medical Solutions USA, Inc
Aug 30, 2021 SOMATOM Definition Flash with software syngo.CT VB20 Model #10430603 software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1... Class II Siemens Medical Solutions USA, Inc
Aug 30, 2021 SOMATOM Force with software syngo.CT VB20 Model #10742326 software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1... Class II Siemens Medical Solutions USA, Inc
Aug 30, 2021 SOMATOM Definition AS with software syngo.CT VB20 Model #8098027 software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1... Class II Siemens Medical Solutions USA, Inc
Aug 30, 2021 SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000 software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1... Class II Siemens Medical Solutions USA, Inc
Aug 27, 2021 Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft versi... When a measurement with a PTW detector array is performed with the software BeamAdjust 2.2 or Ver... Class II PTW NORTH AMERICA CORPORATION
Aug 18, 2021 Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP... Software versions may result in sporadic problems causing scanning workflow interruptions and un... Class II Siemens Medical Solutions USA, Inc
Aug 16, 2021 AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclu... When deleting a previously entered custom isotope, the software deletes the isotope, but not the ... Class II Biodex Medical Systems, Inc.
Aug 16, 2021 Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusiv... When deleting a previously entered custom isotope, the software deletes the isotope, but not the ... Class II Biodex Medical Systems, Inc.
Aug 12, 2021 Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image proce... A software anomaly exists in the Centricity Universal Viewer study management feature in which st... Class II GE Healthcare, LLC
Aug 10, 2021 TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are inten... Software: A coding error associated with the Fast3D Segmentation software. During the scanning p... Class II DePuy Orthopaedics, Inc.
Aug 10, 2021 TRUMATCH CT CUT GUIDE KIT R- TruMatch Patient Specific Instruments are intend... Software: A coding error associated with the Fast3D Segmentation software. During the scanning p... Class II DePuy Orthopaedics, Inc.
Aug 10, 2021 TRUMATCH CT CUT GUIDE FEM L- TruMatch Patient Specific Instruments are intend... Software: A coding error associated with the Fast3D Segmentation software. During the scanning p... Class II DePuy Orthopaedics, Inc.
Aug 10, 2021 TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intend... Software: A coding error associated with the Fast3D Segmentation software. During the scanning p... Class II DePuy Orthopaedics, Inc.
Aug 10, 2021 TRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific Instruments are inte... Software: A coding error associated with the Fast3D Segmentation software. During the scanning p... Class II DePuy Orthopaedics, Inc.
Aug 10, 2021 TRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments are intend... Software: A coding error associated with the Fast3D Segmentation software. During the scanning p... Class II DePuy Orthopaedics, Inc.
Aug 10, 2021 TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intend... Software: A coding error associated with the Fast3D Segmentation software. During the scanning p... Class II DePuy Orthopaedics, Inc.
Aug 6, 2021 EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2... Due to a software defect that can intermittently cause the system to lock-up which exiting Review... Class II Philips Ultrasound Inc
Aug 6, 2021 Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5... Due to a software defect that can intermittently cause the system to lock-up which exiting Review... Class II Philips Ultrasound Inc
Jul 26, 2021 Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10 If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan i... Class II Elekta Inc
Jul 26, 2021 Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, ... Two software issues have been identified related to pressure increase in the device: The first is... Class II Philips Respironics, Inc.
Jul 26, 2021 Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B Two software issues have been identified related to pressure increase in the device: The first is... Class II Philips Respironics, Inc.
Jul 26, 2021 Alinity ci-series System Control Module clinical chemistry and immunoassay an... Due to potential performance issues with software version 3.2.3 and earlier. Performance issues ... Class II Abbott Laboratories

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.