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 |
|---|---|---|---|---|
| Sep 5, 2025 | Brand Name: Branding is not applied to this product. Product Name: DVI displ... | Due to display cables used for monitors were not in compliance with electromagnetic interference ... | Class II | Spacelabs Healthcare, Inc. |
| Sep 5, 2025 | Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm ... | Due to products that have not completed design updates and performance testing being released/dis... | Class II | Exactech, Inc. |
| Sep 5, 2025 | GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with softwar... | GE HealthCare has identified an issue affecting Carescape" Central Station (CSCS) with software v... | Class II | Wipro GE Healthcare Private Ltd. |
| Sep 2, 2025 | This device is a digital radiography/fluoroscopy system used in a diagnostic ... | It has been found that when SPOT Fluoro is first turned on, the default ROI is selected and the c... | Class II | Canon Medical System, USA, INC. |
| Aug 28, 2025 | Sharesource Connectivity Platform for Use with Homechoice Claria Product C... | Vantive has identified a software defect within the Sharesource Claria software, which may cause ... | Class II | Vantive US Healthcare LLC |
| Aug 28, 2025 | Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dex... | A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpec... | Class I | Dexcom, Inc. |
| Aug 22, 2025 | Brand Name: Sonesta Product Name: 6210 Model/Catalog Number: 0120-LA120-03 ... | Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dro... | Class II | Sonesta Medical AB |
| Aug 21, 2025 | Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to iden... | Software version 3.35 of the Venclose digiRF Generator incorporates a catheter verification featu... | Class II | Bard Peripheral Vascular Inc |
| Aug 20, 2025 | ACCOLADE DR SL MRI (Model L311) | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number S722, ALTRUA 2 DR EL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | PROPONENT DR SL (Model L201) | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | ACCOLADE SR SL MRI (Model L310) | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number L100, ESSENTIO SR SL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number U125, VALITUDE CRT-P EL | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | ACCOLADE SR SL (Model L300) | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number L111, ESSENTIO DR SL MRI Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number S701 ALTRUA 2 SR SL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | ACCOLADE DR EL (Model L321) | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | ACCOLADE DR SL (Model L301) | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number L210 PROPONENT SR SL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number U225 VISIONIST CRT-P EL | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number L110, ESSENTIO SR SL MRI Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | ACCOLADE DR EL MRI (Model L331) | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number L131, ESSENTIO DR EL MRI Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number U228, VISIONIST CRT-P EL MRI | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number L101, ESSENTIO DR SL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number L231, PROPONENT DR EL MRI Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number U128, VALITUDE CRT-P EL MRI | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number L211 PROPONENT DR SL MRI Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number L121 ESSENTIO DR EL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number L221 PROPONENT DR EL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | PROPONENT SR SL (Model L200) | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number U226, VISIONIST CRT-P EL | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number L209 PROPONENT DR (VDD) SL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number S702, ALTRUA 2 DR SL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 15, 2025 | BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA0001... | Potential for activation of an abnormal alarm pause. | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Aug 13, 2025 | Change Healthcare Radiology Solutions software version 14.2.2 | Due to software issue, radiology reports may not be fully displayed when viewing. | Class II | CHANGE HEALTHCARE CANADA COMPANY |
| Aug 11, 2025 | Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions ... | Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schill... | Class II | Merge Healthcare, Inc. |
| Aug 11, 2025 | Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use ... | Their is the potential for weak staining which may result in false negative CD20 identification. | Class II | Agilent Technologies Denmark ApS |
| Aug 11, 2025 | Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use ... | Their is the potential for weak staining which may result in false negative CD20 identification. | Class II | Agilent Technologies Denmark ApS |
| Aug 11, 2025 | Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use ... | Their is the potential for weak staining which may result in false negative CD20 identification. | Class II | Agilent Technologies Denmark ApS |
| Aug 8, 2025 | RayStation with the following product descriptions: 1. RayStation 2023B, ... | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's i... | Class II | RAYSEARCH LABORATORIES AB |
| Aug 8, 2025 | RayStation with the following product descriptions: 1. RayStation 7, Soft... | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's i... | Class II | RAYSEARCH LABORATORIES AB |
| Aug 8, 2025 | RayStation with the following product descriptions: 1. RayStation 12A, So... | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's i... | Class II | RAYSEARCH LABORATORIES AB |
| Aug 8, 2025 | RayStation with the following product descriptions: 1. RayStation 10B, So... | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's i... | Class II | RAYSEARCH LABORATORIES AB |
| Aug 8, 2025 | RayStation with the following product descriptions: 1. RayStation 6 Servi... | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's i... | Class II | RAYSEARCH LABORATORIES AB |
| Aug 8, 2025 | RayStation with the following product descriptions: 1. RayStation 9B, Sof... | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's i... | Class II | RAYSEARCH LABORATORIES AB |
| Aug 8, 2025 | RayStation with the following product descriptions: 1. RayStation 11A, So... | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's i... | Class II | RAYSEARCH LABORATORIES AB |
| Aug 8, 2025 | IntelliSpace Cardiovascular, Software 8.0.0.4. | Software issue that results in the display of outdated information. | Class II | Philips Medical Systems Nederland B.V. |
| Aug 8, 2025 | RayStation with the following product descriptions: 1. RayStation 8B, Sof... | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's i... | Class II | RAYSEARCH LABORATORIES AB |
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.