Browse Device Recalls

3,099 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,099 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 3,099 FDA device recalls.

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DateProductReasonClassFirm
Nov 9, 2020 Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product... A software problem has been identified which could result in the CT Scanner not proceeding to th... Class II Canon Medical System, USA, INC.
Nov 9, 2020 icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended fo... Due to a potential software issue, the display may show the incorrect continuous cardiac output (... Class II ICU Medical, Inc.
Nov 3, 2020 Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed o... It has been determined that the software distributed with the retinal camera may delete patient i... Class II Kowa Optimed Inc
Oct 27, 2020 All EPIQ and Affiniti Ultrasound systems. Model numbers - EPIQ 5G, EPIC 5C, E... The manufacturer has determined that with certain uncommon workflows there is potential for incor... Class II Philips Ultrasound Inc
Oct 23, 2020 The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnost... The firm has become aware of nine reports by a single customer that the software made false posit... Class II Biomeme, Inc.
Oct 23, 2020 Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Softw... Stryker has discovered a characterization issue associated with the Mako Integrated Cutting Syste... Class II Mako Surgical Corporation
Oct 9, 2020 cobas infinity central lab/cobas infinity core license-The cobas infinity IT ... Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expira... Class II Roche Diagnostics Operations, Inc.
Oct 8, 2020 RayStation standalone software treatment planning system, Model No. 4.0, 4.5,... If a region of interest (ROI) or point of interest (POI) that is referenced from an imported pla... Class II RAYSEARCH LABORATORIES AB
Sep 28, 2020 VNS Therapy¿ AspireSR¿ Generator Due to an extra digit being inadvertently added to the serial number of a subset of implantable p... Class II LivaNova USA Inc
Sep 22, 2020 9310HD Digital Video Capture Module with software version 3.4.0 or higher con... There is an intermittent software issue that could affect the systems, in which an exam video for... Class II Pentax of America Inc
Sep 22, 2020 Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSI... There is potential when a user changes an EGM trace channel with a Manual Pace Threshold test in ... Class II Boston Scientific Corporation
Sep 22, 2020 9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal), There is an intermittent software issue that could affect the systems, in which an exam video for... Class II Pentax of America Inc
Sep 18, 2020 ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intende... There is a software problem which affects the DSA Roadmap application on ARTIS Icono and ARTIS Ph... Class II Siemens Medical Solutions USA, Inc
Sep 12, 2020 Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR18... The device may detect an incorrect Heater Bag volume which may lead to a 'Supply Bag Line Blocked... Class II Fresenius Medical Care Holdings, Inc.
Sep 11, 2020 Synapse PACS Software Versions 5.1 and higher There is a potential for the wrong patient information may be displayed in the viewer or PowerJac... Class II Fujifilm Medical Systems U.S.A., Inc.
Sep 11, 2020 Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a we... FUJIFILM has become aware of the possibility that certain CT studies may report a much higher 3D ... Class II Fujifilm Medical Systems U.S.A., Inc.
Sep 7, 2020 Neoprobe GDS Control Unit, Model Number NPCU3 It was discovered during a documentation review that China has the software version as v5.01 appr... Class III Devicor Medical Products Inc
Aug 31, 2020 Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cr... Brainlab Ultrasound Navigation Software does not support the modification of the probe's image wi... Class II Brainlab AG
Aug 25, 2020 Change Healthcare Radiology Solutions 14.0 Software defect which may potentially result in one or more images missing in a study Class II CHANGE HEALTHCARE CANADA COMPANY
Aug 19, 2020 Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_... Calibration offset between the central CT image plane and the external RT lasers has been set aut... Class II Siemens Medical Solutions USA, Inc
Aug 6, 2020 The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretiv... COVID-19 Interpretive Software issues that may cause: 1) the risk of invalid or inconclusive tes... Class II Life Technologies Corporation
Aug 6, 2020 PC Application Software c4D as part of the device Catalyst: SP-002 Software P... PC Application Software c4D not changing Site upon synchronization during the Setup workflow step Class II C-RAD POSITIONING AB
Aug 6, 2020 The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretiv... COVID-19 Interpretive Software issues that may cause: 1) the risk of invalid or inconclusive tes... Class II Life Technologies Corporation
Jul 29, 2020 RayCare, device is stand-alone software - Product Usage: used to support work... When performing offline image review in RayCare 2C, RayCare 3A and RayCare 3B an offline image re... Class II RAYSEARCH LABORATORIES AB
Jul 22, 2020 CombiDiagnost R90 Software Version R1.0 and R1.1 Philips has become aware of a software issue, where the kV and mA values are not locked immediate... Class II Philips Medical Systems Gmbh, DMC
Jul 17, 2020 Restore Clinician Programmer Application Software, model number A71100, used... The original version of the A71100 Restore Clinician Programmer Application has been identified t... Class II Medtronic Neuromodulation
Jul 15, 2020 The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by pat... As a result of the release of new software version to CareLink Personal website, the IOS app for ... Class II Medtronic Inc.
Jul 15, 2020 OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems wi... There are potential issues related to the operational state of the scanner, specifically for tran... Class II NeuroLogica Corporation
Jul 15, 2020 SICAT IMPLANT V2.0 A dentist found implant positions are not correctly exported from the implant planning software S... Class II SICAT GMBH & CO. KG
Jul 13, 2020 Medtronic SynchroMed, Model A10 The previous software application version (1.1.300) is missing a decimal separator (a comma) for ... Class II Medtronic Inc.
Jul 5, 2020 DYNEX Agility, Agility Analyzer, Model No. 67000 Control samples aspirated from wrong SmartKit on the Agility. Agility software was updated to v1.... Class II Dynex Technologies, Inc.
Jun 30, 2020 Spectrum IQ Infusion System with Dose IQ Safety Software Baxter is updating the device IFU for safety communication regarding cleaning practices. Class I Baxter Healthcare Corporation
Jun 26, 2020 Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump. Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific seque... Class I Smiths Medical ASD Inc.
Jun 26, 2020 Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, ... Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific seque... Class I Smiths Medical ASD Inc.
Jun 24, 2020 syngo.via RT Image Suite with software versions syngo.via VB30 or VB40 If the user modifies for any reason (e.g. reduction of artifacts) the original image orientation ... Class II Siemens Medical Solutions USA, Inc
Jun 22, 2020 Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATO... Sporadic problems with the current software may result in scanning workflow interruptions and une... Class II Siemens Medical Solutions USA, Inc
Jun 22, 2020 CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usa... Software defect may result in disapperance of tag sites during recalculation and lead to addition... Class II Biosense Webster (israel), Ltd.
Jun 19, 2020 Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series ... Quality Control results were not properly evaluated for QC failures. Class II Abbott Gmbh & Co. KG
Jun 12, 2020 Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is ind... During internal testing execution of the next generation of Integrated Power Console (IPC) protot... Class II Medtronic Xomed, Inc.
May 26, 2020 RayStation standalone software treatment planning system (RayStation 8A, 8B, ... It is not obvious that the manual import of a treatment record into RayCare PACS does not automat... Class II RAYSEARCH LABORATORIES AB
May 26, 2020 Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 3... Potential risk of patient mix-up on analyzers due to software issues. Class II Radiometer Medical ApS
May 26, 2020 Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 3... Potential risk of patient mix-up on analyzers due to software issues. Class II Radiometer Medical ApS
May 22, 2020 Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interfac... Lateromedial (LM) and Lateromedial Oblique (LMO) Orientation Markers may be displayed incorrectly... Class II Fujifilm Medical Systems U.S.A., Inc.
May 21, 2020 Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, ... In TSM (Treatment Session Manager) Motion Monitoring workflows, under certain conditions there ca... Class II Elekta Limited
May 21, 2020 VistaSolution, physiological signal transmitter. A software graphical user in... A healthcare provider (HCP) noticed a patient had a lowered historic SpO2 reading that the softwa... Class II Vitalconnect Inc.
May 20, 2020 VITROS 5600 Integrated System Software Versions 3.3.3 and below Product C... Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset ... Class II Ortho Clinical Diagnostics
May 20, 2020 VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Produ... Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset ... Class II Ortho Clinical Diagnostics
May 20, 2020 VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below... Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset ... Class II Ortho Clinical Diagnostics
May 20, 2020 VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Produc... Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset ... Class II Ortho Clinical Diagnostics
May 18, 2020 RayStation 8B Service Pack 1, UDI # 07350002010204 - Product Usage: For radi... Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... Class II RAYSEARCH LABORATORIES AB

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.