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Browse Device Recalls

100 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 100 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 100 FDA device recalls.

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DateProductReasonClassFirm
Dec 14, 2025 Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, ... Due to a manufacturing issue and electrical grounding of systems. Class II Elekta, Inc.
Dec 12, 2025 Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planni... Due to an error when defining a new stereotactic reference that users fail to first change an alr... Class II Elekta, Inc.
Dec 12, 2025 Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planni... Due to an error when defining a new stereotactic reference that users fail to first change an alr... Class II Elekta, Inc.
Dec 10, 2025 MOSAIQ Oncology Information System with Particle Therapy License (License Ki... Using oncology information system that manages workflow may result in overtreatment if:Plan deliv... Class II Elekta, Inc.
Sep 30, 2025 Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereo... Due to increased risk that paint flakes from the engravings may separate from the device and ther... Class II Elekta, Inc.
Jan 15, 2025 MOSAIQ Oncology Information System Image offsets calculated by oncology Information System software may be incorrect for Linear A... Class II Elekta, Inc.
Oct 25, 2023 ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical C... Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there i... Class II Elekta, Inc.
Oct 25, 2023 ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Partic... Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there i... Class II Elekta, Inc.
Oct 25, 2023 ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation T... Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there i... Class II Elekta, Inc.
Oct 25, 2023 ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiati... Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there i... Class II Elekta, Inc.
Oct 25, 2023 ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charg... Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there i... Class II Elekta, Inc.
Oct 25, 2023 ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; M... Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there i... Class II Elekta, Inc.
May 5, 2023 Elekta Medical Linear Accelerator (ELMA) included in the below platforms: ... A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC... Class II Elekta, Inc.
Apr 6, 2023 Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient ... There is a low possibility that an electrical connector in the MR gradient coil will overheat on ... Class II Elekta, Inc.
Dec 5, 2022 Oncentra Brachy radiation therapy planning system software. A reconstruction error may occur when using the Catheter Bending functionality in Applicator Mode... Class II Elekta, Inc.
Oct 13, 2021 Oncentra Brachy users using version 4.0 and above with Applicator Modeling li... Under certain circumstances, there can be a difference between the planned and delivered dose of ... Class II Elekta, Inc.
Sep 17, 2021 Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta... There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed ... Class II Elekta, Inc.
Sep 2, 2021 MOSAIQ Oncology Information System A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved ... Class II Elekta, Inc.
Apr 20, 2021 Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, ... Malware attack Class II Elekta, Inc.
Apr 30, 2020 Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Pro... potential risk that Legionella may be present in the Unity machine room, specifically the heat ex... Class II Elekta, Inc.
Dec 18, 2019 Elekta Unity, Image-Guided Radiation Therapy System There have been reports of excessive heating in the MRL Gradient Connection Module. Class II Elekta, Inc.
Aug 23, 2019 Monaco Radiation Treatment Planning System (RTP) System Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setu... Class II Elekta, Inc.
Jun 24, 2019 Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Mag... The QA software solution to perform the MR to MV alignment check, does not display the stored MR ... Class II Elekta, Inc.
Jun 19, 2019 iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2 Potential for iGUIDE to incorrectly monitor the 3D position. Class II Elekta, Inc.
Feb 8, 2019 Monaco Radiation Treatment Planning (RTP) System If Improve Target Dose was chosen as an optimization model in a previous treatment session, Mon... Class II Elekta, Inc.
Dec 13, 2018 MOSAIQ¿ Oncology Information System and Sequencer MOSAIQ is an oncology in... There is a potential that Wedge IDs were not included in the DICOM RT PLAN sent from the TPS, whi... Class II Elekta, Inc.
Dec 4, 2018 MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology i... If a Setup field (CT, kV, MV or MVCT) is created by COPYING a treatment field or another setup fi... Class II Elekta, Inc.
Aug 3, 2018 MOSAIQ Oncology Information System Order Status Remains Approved When Should Indicate Complete. Class II Elekta, Inc.
May 16, 2018 HexaPOD evo RT Couch Top (also known as HexaPOD evo Module), a component of t... Upon completion of a 6D workflow, the HexaPOD evo Module may be in a tilted state if it is moved ... Class II Elekta, Inc.
Dec 1, 2017 ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, S... There is a potential for an uncontrolled extension of iViewGT / XVI detector arms. Class II Elekta, Inc.
Jun 30, 2017 MOSAIQ Medical Charged-Particle Radiation Therapy System The table shift in the vertical direction was inverted during the use of CMA (Couch Move Assistan... Class II Elekta, Inc.
Jun 21, 2017 MOSAIQ(R) Oncology Information System, Versions 2.50.05 and higher Product... Retention of Outdated Information in an Order Set. In the Care Plan Library, double clicking to ... Class II Elekta, Inc.
Jun 19, 2017 iGUIDE Software 2.2 Product Usage: Control of accurate patient positioni... Incorrect PEC values. Class II Elekta, Inc.
May 23, 2017 Leksell Gamma Knife Icon is a teletherapy device intended for stereotactic ir... If the gantry module is replaced after original installation the configuration settings may be mi... Class II Elekta, Inc.
Jan 10, 2017 Monaco RTP System. Used to make treatment plans for patients with prescrip... Incorrect dose after editing beam number an wedge angle. Class II Elekta, Inc.
Dec 23, 2016 Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiati... Cross profile for Varian 60 degree wedge shows "horns." Class II Elekta, Inc.
Dec 21, 2016 Monaco RTP System Product Usage: Used to make treatment plans for patient... Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations. Class II Elekta, Inc.
Dec 2, 2016 MOSAIQ Oncology Information System The product is used to manage workflow... Edits to Particle field definition parameters may not be saved when the field definition window i... Class II Elekta, Inc.
Nov 17, 2016 Monaco TRP System The Monaco system is used to make treatment plans for pati... Contours are not handled correctly if the CT dataset contains slices with DICOM Z coordinates of ... Class II Elekta, Inc.
Nov 3, 2016 Monaco RTP System; Used to make treatment plans for patients with prescriptio... Incorrect Dose when using the reset function. Class II Elekta, Inc.
Sep 29, 2016 Monaco RTP System The Monaco system is used to make treatment plans for pati... When creating 3D plans using either MU or Dose weighting modes, if the user changes the Physician... Class II Elekta, Inc.
Aug 18, 2016 Monaco RTP System Used to make treatment plans for patients with prescript... In a specific workflow where contours are edited (enlarged, moved, copied, etc.) and then the con... Class II Elekta, Inc.
Aug 18, 2016 HexaPOD evo RT System Product Usage: The intended use of the device is th... Potentially unrecognized incorrect position of the treatment couch in 3D workflow, i.e. the HexaP... Class II Elekta, Inc.
Jul 15, 2016 MOSAIQ Oncology Information System It is possible that a change to an Order Set will not be saved in the current open Care Plan. Thi... Class II Elekta, Inc.
Jul 8, 2016 Medical Linear Accelerator There have been instances in hospitals where the joint between the drive gear and the gantry base... Class II Elekta, Inc.
Jun 17, 2016 MOSAIQ Oncology Information System It is possible that that the selected Plan-of-the Day could be accidently changed by scrolling th... Class II Elekta, Inc.
May 18, 2016 Monaco RTP System Product Usage: The Monaco system is used to make treatm... When DICOM exporting a 3D Monaco plan and the "Composite Field Sequencing" (CFS) checkbox is sele... Class II Elekta, Inc.
May 12, 2016 iGUIDE System, for patient positioning, with assistance of a 30 Tracking Syst... If by mistake the initial pre-treatment imaging was performed BEFORE the HexaPOD was moved to the... Class II Elekta, Inc.
Apr 19, 2016 Radionuclide Radiation Therapy System Product The product is a teletherapy... The latches of the frame adapter can be locked even if the locating pins of the frame adapter is ... Class II Elekta, Inc.
Dec 18, 2015 Oncentra External Beam - VMAT - Radiation therapy planning system Product ... When using the option "Tumor Overlap Fraction" in VMAT planning it has been observed that in rare... Class II Elekta, Inc.

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.