Browse Device Recalls
3,007 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,007 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 3,007 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 18, 2020 | Trinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-... | The firm has identified a problem with the control software for the celling arm of the X-Ray Syst... | Class II | Shimadzu Medical Systems |
| Nov 18, 2020 | Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspe... | The firm has identified a problem with the control software for the celling arm of the X-Ray Syst... | Class II | Shimadzu Medical Systems |
| Nov 18, 2020 | MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intend... | The firm has identified a problem with the control software for the celling arm of the X-Ray Syst... | Class II | Shimadzu Medical Systems |
| Nov 17, 2020 | Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.... | A software error was detected within software version 1.3.4 for the Tempus LS device. When exitin... | Class II | Remote Diagnostic Technologies Ltd. |
| Nov 16, 2020 | Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN... | The firm has released software update V01.05.02.16 (also known as V1.5.2) in response to customer... | Class II | Covidien Llc |
| Nov 12, 2020 | Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Progra... | A710 Intellis Clinician Application has a software issue that can result in the inability to prog... | Class II | Medtronic Neuromodulation |
| Nov 12, 2020 | CareLink Personal Software Therapy Management Software Tool for Diabetes Car... | Incomplete basal rate information may be transmitted leading to a potential for inappropriate cha... | Class II | Medtronic Inc. |
| Nov 11, 2020 | Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A | A software problem has been identified which could result in the diagnostic imaging system not p... | Class II | Canon Medical System, USA, INC. |
| 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 |
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.