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 |
|---|---|---|---|---|
| Jan 26, 2024 | VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 680291... | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC basel... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jan 26, 2024 | VITROS XT 7600 Integrated System, Catalog No. 6844461 | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 cause... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jan 26, 2024 | VITROS XT 3400 Chemistry System, Catalog No. 6844458 | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC basel... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jan 26, 2024 | VITROS XT 7600 Integrated System, Catalog No. 6844461 | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC basel... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jan 26, 2024 | VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (ref... | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC basel... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jan 3, 2024 | Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; ... | A software error caused an increase in tray gripper motion errors that causes intermittent hard s... | Class II | Beckman Coulter, Inc. |
| Jan 3, 2024 | 1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Comm... | Due to software and controller systems that results in unexpected pump start or pump stop. | Class I | Thoratec Corp. |
| Dec 27, 2023 | Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible... | Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately | Class II | TruAbutment Inc. |
| Dec 22, 2023 | Baxter Exactamix Pro 2400, REF EXM24DY | An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" ... | Class I | Baxter Healthcare Corporation |
| Dec 22, 2023 | Baxter Exactamix Pro 1200, REF EXM12DY | An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" ... | Class I | Baxter Healthcare Corporation |
| Dec 20, 2023 | Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenou... | When utlizing the patient query feature on the Zyno Medical Z-800WF pumps with software version 5... | Class II | Zyno Medical LLC |
| Dec 19, 2023 | smiths medical Medfusion Model 4000 syringe pump | Medfusion Model 4000 syringe infusion pumps, with the following software versions, may have the f... | Class I | Smiths Medical ASD Inc. |
| Dec 19, 2023 | smiths medical Medfusion Model 3500 Syringe pump | Medfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. D... | Class I | Smiths Medical ASD Inc. |
| Dec 13, 2023 | Spectral CT on Rails: Software Version 5.1.0.X, model 728334. | A software issue that can incorrectly label all captured images that may lead to misdiagnosis and... | Class II | PHILIPS MEDICAL SYSTEMS |
| Dec 13, 2023 | Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 Chi... | A software issue that can incorrectly label all captured images that may lead to misdiagnosis and... | Class II | PHILIPS MEDICAL SYSTEMS |
| Dec 8, 2023 | Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table... | Loss of connectivity between the FlexArm and the Table due to a software issue related to the dat... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 8, 2023 | WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Deskto... | Following an FDA-issued Warning Letter, the firm requested return of their research EEG system co... | Class II | WAVi Co. |
| Dec 8, 2023 | Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table... | Loss of connectivity between the FlexArm and the Table due to a software issue. | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 7, 2023 | Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2... | During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 7, 2023 | Philips Azurion 7B20/15, Model Numbers: 722068, 722226 with Software release... | During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 7, 2023 | Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2... | During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 7, 2023 | Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2... | During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 7, 2023 | Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2... | During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 7, 2023 | Philips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release... | During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 7, 2023 | Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.... | During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 7, 2023 | Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2... | During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 6, 2023 | Impella Connect, software portal for online device management that allows cli... | The following features have been disabled from the web-based portal because the FDA has not evalu... | Class II | Abiomed, Inc. |
| Nov 30, 2023 | Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System. | Multiple software issues that affect device functionality. | Class II | Philips North America Llc |
| Nov 30, 2023 | Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) ... | The software application on the Programmer/Recorder/Monitor (PRM) for Implantable Pulse Generator... | Class II | Boston Scientific Corporation |
| Nov 30, 2023 | Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.... | The bolus calculator is not recording the decimal point if it is the first value entered when cha... | Class I | Insulet Corporation |
| Nov 21, 2023 | DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior, | There are potential performance issues found in the DxI 9000 Access Immunoassay Analyzer, includi... | Class II | Beckman Coulter, Inc. |
| Nov 16, 2023 | Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10G... | Due to software issue, New systems may exhibit an error which may prohibit use of new systems res... | Class II | Covidien |
| Nov 15, 2023 | The device is an X-ray system that is capable of radiographic and fluoroscopi... | VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal image... | Class II | Canon Medical System, USA, INC. |
| Nov 1, 2023 | Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Mo... | A software issue where "low" and "terminal" battery alerts did not display on the screen to the u... | Class II | Turncare, Inc |
| Oct 19, 2023 | epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), ... | Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under certai... | Class II | Siemens Healthcare Diagnostics Inc |
| Oct 18, 2023 | Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w | Their is the potential that software issues may result in flipped image of the virtual Bronchosc... | Class II | AURIS HEALTH INC |
| Oct 18, 2023 | Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w | Their is the potential that software issues may result in flipped image of the virtual Bronchosc... | Class II | AURIS HEALTH INC |
| Oct 18, 2023 | Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w | Their is the potential that software issues may result in flipped image of the virtual Bronchosc... | Class II | AURIS HEALTH INC |
| Oct 17, 2023 | SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System | Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements. | Class II | Bebig Isotopentechnik Gmbh |
| Oct 12, 2023 | Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2... | Change Healthcare has identified a software issue where Change Healthcare Radiology Solutions 14.... | Class II | CHANGE HEALTHCARE CANADA COMPANY |
| Oct 10, 2023 | Automated Impella Controller (AIC), product number 0042-000-US with software ... | Pump not detected as connected to controller due to software issue. | Class II | Abiomed, Inc. |
| Oct 10, 2023 | VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Prod... | During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence ... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Oct 10, 2023 | VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Co... | During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence ... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Oct 10, 2023 | VITROS XT 7600 Integrated System Product Code 6844461 Running Software Versio... | During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence ... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Oct 10, 2023 | Automated Impella Controller (AIC), product number 0042-040-US with software ... | Pump not detected as connected to controller due to software issue. | Class II | Abiomed, Inc. |
| Oct 10, 2023 | VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Cod... | During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence ... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Oct 10, 2023 | VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version... | During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence ... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Oct 9, 2023 | Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728... | For oncology users: If the user performed off-set reconstruction on CT device a shift could be ob... | Class II | Philips North America Llc |
| Oct 9, 2023 | Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), E... | Their is the potential that diagnostic ultrasound systems operating with software version 10.0 ma... | Class II | Philips Ultrasound, Inc. |
| Oct 9, 2023 | Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 | When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the ope... | Class II | Philips North America |
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.