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 |
|---|---|---|---|---|
| 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 |
| Oct 9, 2023 | Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210 | Their is the potential that diagnostic ultrasound systems operating with software version 10.0 ma... | Class II | Philips Ultrasound, Inc. |
| Oct 9, 2023 | Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner ... | 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 | Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT... | 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 | Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 | This recall is part of a 2-issue recall for the same system. When using the IVC needle position b... | Class II | Philips North America |
| Oct 6, 2023 | ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robot... | Users of the patient positioning system ORION System can be faced with a sudden short-term accele... | Class II | LEONI CIA CABLE SYSTEMS |
| Oct 6, 2023 | ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robot... | Users of the patient positioning system ORION System can be faced with a sudden short-term accele... | Class II | LEONI CIA CABLE SYSTEMS |
| Oct 5, 2023 | MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00;... | If "Clear All" selected medications is selected on patient profile, the automated dispensing cabi... | Class II | CareFusion 303, Inc. |
| Oct 2, 2023 | The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system ut... | There is a potential for unexpected failure of the electrical components within the Carestream He... | Class II | Carestream Health, Inc. |
| Sep 27, 2023 | StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The Ste... | Due to a software anomaly which potentially could result in the surgical planning data shifting t... | Class I | Medtronic Navigation, Inc. |
| Sep 21, 2023 | TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with ... | When using affected curette and software, there is a discrepancy between the actual curette tip l... | Class II | Acclarent, Inc. |
| Sep 19, 2023 | NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pi... | Eye syncing issues causing the device to be inoperable. Unable to be repaired due to discontinuat... | Class II | NeuroSync, Inc. |
| Sep 15, 2023 | Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ... | Asensus Surgical has identified a malfunction that has occurred and may recur on the Senhance Sur... | Class I | Asensus Surgical Inc |
| Sep 14, 2023 | Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiologica... | GE HealthCare has become aware of an issue where images from two different patients may be contai... | Class II | GE Healthcare |
| Sep 14, 2023 | Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Rad... | GE HealthCare has become aware of an issue where images from two different patients may be contai... | Class II | GE Healthcare |
| Sep 12, 2023 | Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed fo... | Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirem... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 12, 2023 | ***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray Sy... | Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirem... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 11, 2023 | Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural... | Infusion Pumps with affected software revision may fail to detect air in line, which may lead to ... | Class I | EITAN MEDICAL LTD |
| Sep 7, 2023 | Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software ve... | CORI software was missing a planning stage that appears in cases of significant knee deformation ... | Class II | Blue Belt Technologies, Inc |
| Sep 5, 2023 | MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 ... | Software update | Class II | Mazor Robotics Ltd |
| Aug 31, 2023 | EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidest... | A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (... | Class II | Philips North America Llc |
| Aug 31, 2023 | EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream e... | A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (... | Class II | Philips North America Llc |
| Aug 30, 2023 | CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Genera... | Ultrasound devices were not authorized, cleared, or approved by FDA, and thus their performance c... | Class II | RoyalVibe Health Ltd. |
| Aug 18, 2023 | BD Pyxis MedBank MedPass Software, REF: 139088-01 | After dispensing a timed dose medication for a patient, the automated dispensing cabinet software... | Class II | CareFusion 303, Inc. |
| Aug 17, 2023 | SOZO Bilateral Arm L-Dex Software | Bilateral L-Dex assessment software does not have the same level of sensitivity to help detect ea... | Class II | Impedimed Limited |
| Aug 17, 2023 | exoplan version 3.1 Rijeka Software -A medical software, intended to support ... | A software library filtering error has been discovered which occurs when users are using the Step... | Class II | Exocad GmbH |
| Aug 17, 2023 | Patient Information Center iX with Software Version Number 4.x in the followi... | Patient Information Center (PIC iX) Release 4.x Surveillance Crash Caused by Intel Graphics Driv... | Class II | Philips North America Llc |
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.