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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| May 18, 2020 | RayStation 6 Service Pack 1, UDI #s 07350002010037, 07350002010082 - Produ... | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... | Class II | RAYSEARCH LABORATORIES AB |
| May 18, 2020 | RayStation 9B, UDI # 07350002010266 - Product Usage: For radiation therapy a... | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... | Class II | RAYSEARCH LABORATORIES AB |
| May 18, 2020 | RayStation 6, UDI # 07350002010013 - Product Usage: For radiation therapy and... | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... | Class II | RAYSEARCH LABORATORIES AB |
| May 18, 2020 | RayStation 4.0 to RayStation 5 Service Pack 2 - Product Usage: For radiation ... | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... | Class II | RAYSEARCH LABORATORIES AB |
| May 18, 2020 | RayStation 8B Service Pack 2, UDI # 07350002010235 - 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 |
| May 18, 2020 | RayStation 7, UDI # 07350002010068 - Product Usage: For radiation therapy an... | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... | Class II | RAYSEARCH LABORATORIES AB |
| May 18, 2020 | RayStation 8A, UDI # 07350002010112 - Product Usage: For radiation therapy an... | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... | Class II | RAYSEARCH LABORATORIES AB |
| May 18, 2020 | RayStation 9B Service Pack 1, UDI # 07350002010297 - 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 |
| May 18, 2020 | RayStation 8B, UDI # 07350002010129 - Product Usage: For radiation therapy a... | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... | Class II | RAYSEARCH LABORATORIES AB |
| May 18, 2020 | RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation therapy a... | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... | Class II | RAYSEARCH LABORATORIES AB |
| May 18, 2020 | RayStation 6 Service Pack 3, UDI # 07350002010242 - Product Usage: For radiat... | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... | Class II | RAYSEARCH LABORATORIES AB |
| May 18, 2020 | RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiat... | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... | Class II | RAYSEARCH LABORATORIES AB |
| May 18, 2020 | RayStation 8A Service Pack 1, UDI # 07350002010136 - 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 |
| May 18, 2020 | RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage: For radia... | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... | Class II | RAYSEARCH LABORATORIES AB |
| May 15, 2020 | (1) Atellica Data Manager software version 1.0 Siemens Material Number (SMN)... | Unexpected interface driver behavior identified (QC) Results May Be Assigned to an Incorrect Cont... | Class II | Siemens Healthcare Diagnostics, Inc. |
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.