Browse Device Recalls
2,945 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,945 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 2,945 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Aug 16, 2023 | Medfusion Syringe Pump, Model 4000-XXXX-XX: a) 0100-50, b) 0100-249, c) ... | A force sensor in the occlusion detector may drift out of calibration leading to increased occlus... | Class II | Smiths Medical ASD Inc. |
| Aug 16, 2023 | Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0... | A force sensor in the occlusion detector may drift out of calibration leading to increased occlus... | Class II | Smiths Medical ASD Inc. |
| Aug 10, 2023 | Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Mo... | A software update corrected an issue where "low" and "terminal" battery alerts did not display on... | Class II | Turncare, Inc |
| Aug 10, 2023 | Functional MR V1.0 | When exporting regions of interest in DICOM SEGMENTATION format, when simultaneously exporting mu... | Class II | OLEA MEDICAL |
| Aug 10, 2023 | Baxter Epiphany Cardio Server E3 ECG Management System Servers with software ... | Epiphany, now a Baxter Healthcare company, is issuing an Urgent Medical Device Correction for the... | Class II | Baxter Healthcare Corporation |
| Aug 2, 2023 | Incisive CT, software version 5.0 | Philips has identified three software issues with compliance concerns to Subchapter J: Issue 1: C... | Class II | Philips Healthcare |
| Jul 25, 2023 | ZVU Functional GI Software, REF: ZVU-3 | GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0. | Class III | Diversatek Healthcare |
| Jul 17, 2023 | RayCare software, include version number 5A, 5B, 6A, including service packs-... | An issue was found in Software RayCare 5A, 5B, 6A, including service packs, where an allergy warn... | Class II | RAYSEARCH LABORATORIES AB |
| Jul 10, 2023 | SurgiCount+ Software Application-indicated as an adjunctive technology for au... | Potential for current software to miscount when scanning in multiple sponge-products from the sam... | Class II | Stryker Corporation |
| Jun 26, 2023 | Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software | Software issue | Class II | Digisonics, Inc |
| Jun 21, 2023 | A901 Communication Manager Application, used in conjunction with the A710 Cli... | When an update to the A710 Clinician Programmer software application for the Intellis Neurostimul... | Class II | Medtronic Neuromodulation |
| Jun 15, 2023 | SIGMA Spectrum Infusion Pump, Product Code 35700BAX2 | A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and ... | Class I | Baxter Healthcare Corporation |
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.