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Browse Device Recalls

113 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 113 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 113 FDA device recalls.

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DateProductReasonClassFirm
Nov 28, 2025 RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStatio... Potential for the invalidation for calculated radiation dose does not work as intended for certai... Class II RAYSEARCH LABORATORIES AB
Nov 28, 2025 Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Numbe... Potential for the invalidation for calculated radiation dose does not work as intended for certai... Class II RAYSEARCH LABORATORIES AB
Nov 28, 2025 RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. S... Potential for the invalidation for calculated radiation dose does not work as intended for certai... Class II RAYSEARCH LABORATORIES AB
Nov 28, 2025 Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Numbe... Potential for the invalidation for calculated radiation dose does not work as intended for certai... Class II RAYSEARCH LABORATORIES AB
Nov 28, 2025 RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12... Potential for the invalidation for calculated radiation dose does not work as intended for certai... Class II RAYSEARCH LABORATORIES AB
Nov 28, 2025 Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Numbe... Potential for the invalidation for calculated radiation dose does not work as intended for certai... Class II RAYSEARCH LABORATORIES AB
Nov 28, 2025 Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Numbe... Potential for the invalidation for calculated radiation dose does not work as intended for certai... Class II RAYSEARCH LABORATORIES AB
Nov 28, 2025 Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Numbe... Potential for the invalidation for calculated radiation dose does not work as intended for certai... Class II RAYSEARCH LABORATORIES AB
Nov 28, 2025 Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Numbe... Potential for the invalidation for calculated radiation dose does not work as intended for certai... Class II RAYSEARCH LABORATORIES AB
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 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
Aug 8, 2025 RayStation with the following product descriptions: 1. RayStation 11B, So... DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's i... Class II RAYSEARCH LABORATORIES AB
Jan 16, 2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Jan 16, 2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Jan 16, 2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Jan 16, 2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Jan 16, 2025 Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Jan 16, 2025 Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning Sys... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Jan 16, 2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Jan 16, 2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Jan 16, 2025 Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Jan 16, 2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Jan 16, 2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Mar 28, 2024 RayStation 9.1.0.933 and 9.2.0.483. Radiation Therapy Treatment Planning System. Potential for reported SSD to be too high. Class II RAYSEARCH LABORATORIES AB
Mar 28, 2024 RayStation 14.0.0.3338. Radiation Therapy Treatment Planning System. Potential for reported SSD to be too high. Class II RAYSEARCH LABORATORIES AB
Mar 28, 2024 RayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119. Radiati... Potential for reported SSD to be too high. Class II RAYSEARCH LABORATORIES AB
Mar 28, 2024 RayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning Sys... Potential for reported SSD to be too high. Class II RAYSEARCH LABORATORIES AB
Mar 28, 2024 RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy Treatment Pl... Potential for reported SSD to be too high. Class II RAYSEARCH LABORATORIES AB
Mar 28, 2024 RayStation 7.0.0.19. Radiation Therapy Treatment Planning System. Potential for reported SSD to be too high. Class II RAYSEARCH LABORATORIES AB
Mar 28, 2024 RayStation 15.0.0.430. Radiation Therapy Treatment Planning System. Potential for reported SSD to be too high. Class II RAYSEARCH LABORATORIES AB
Mar 28, 2024 RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System. Potential for reported SSD to be too high. Class II RAYSEARCH LABORATORIES AB
Mar 28, 2024 RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. Radiation Therapy ... Potential for reported SSD to be too high. Class II RAYSEARCH LABORATORIES AB
Mar 28, 2024 RayStation 9.0.0.113 and 9.0.1.142. Radiation Therapy Treatment Planning System. Potential for reported SSD to be too high. Class II RAYSEARCH LABORATORIES AB
Mar 28, 2024 RayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5. Radiation Therapy Treatment Plannin... Potential for reported SSD to be too high. Class II RAYSEARCH LABORATORIES AB
Mar 28, 2024 RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment ... Potential for reported SSD to be too high. Class II RAYSEARCH LABORATORIES AB
Feb 23, 2024 RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A... A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si,... Class II RAYSEARCH LABORATORIES AB
Sep 12, 2023 RayCare 5B and 6A including service packs- An oncology information system use... An issue was found in RayCare 5B, 6A, including service packs, where values will not be visible f... Class II RAYSEARCH LABORATORIES AB
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
Feb 17, 2023 Raystation treatment planning system for radiation therapy, Model Numbers 9.0... It is possible to set a non-zero collimator angle in the Virtual Simulation module. The angle wil... Class II RAYSEARCH LABORATORIES AB
Jun 10, 2022 RayStation 11B This notice concerns two issues found related to the display of Linear Energy Transfer (LET) in R... Class II RAYSEARCH LABORATORIES AB
Jun 1, 2022 RayStation 9B SP1. For radiation treatment planning. An issue with propagation of treatment course information from RayStation with RayTreat to RayCar... Class II RAYSEARCH LABORATORIES AB
Dec 30, 2021 RayStation/RayPlan- designed for treatment planning and analysis of radiation... If a new primary image set is selected while the cine loop is running, the primary image set will... Class II RAYSEARCH LABORATORIES AB
Sep 22, 2021 RayStation/RayPlan versions 4 - 11A, including service packs. Build Stations... An issue where the combined density in a dose grid voxel partially covered by the External ROI an... Class II RAYSEARCH LABORATORIES AB
Sep 9, 2021 TomoHelical and TomoDirect plans in RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B... If the dynamic jaw mode is used and an optimization is continued after changing the dose grid or ... 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.