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Browse Device Recalls

36 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 36 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 36 FDA device recalls.

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DateProductReasonClassFirm
Feb 3, 2026 IBA Proton Therapy System - PROTEUS 235 It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy S... Class II Ion Beam Applications S.A.
Jul 10, 2024 IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a pr... Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasi... Class II Ion Beam Applications S.A.
Jul 8, 2024 IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Softwar... Safety Parameters Verification Mechanisms can be deactivated in clinical runtime Class II Ion Beam Applications S.A.
May 10, 2024 IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a p... Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are ou... Class II Ion Beam Applications S.A.
Mar 4, 2024 IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, an... There is a risk of mistreatment as irradiation is not prevented when some safety parameters are o... Class II Ion Beam Applications S.A.
Sep 18, 2023 IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions wit... The patient positioning system can perform motions in unexpected directions, creating the potenti... Class II Ion Beam Applications S.A.
Apr 20, 2022 Proteus235- Proton Therapy System: to produce and deliver a proton beam for ... First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning ... Class II Ion Beam Applications S.A.
Feb 15, 2022 ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for... When resuming from a beam pause, the Proton Therapy System does not verify whether the beam range... Class II Ion Beam Applications S.A.
Nov 29, 2021 Proteus 235; Version: PTS-8 versions before PTS-8.7.2 Proton Therapy System (PTS) software can be started in the clinical environment (clinical user) ... Class II Ion Beam Applications S.A.
Jun 14, 2021 Proteus 235- designed to produce and deliver a proton beam for the treatment ... Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology... Class II Ion Beam Applications S.A.
May 26, 2021 Proteus 235-Proton Therapy System if the user forgets to select the trigger input manually while beam gating is prescribed for the... Class II Ion Beam Applications S.A.
Jul 17, 2020 Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Pl... IBA became aware of an issue to resume aborted irradiations because the plan to complete the trea... Class II Ion Beam Applications S.A.
Apr 21, 2020 Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus P... Signature from the user is necessary to proceed with specific actions in the Proton Therapy Syste... Class II Ion Beam Applications S.A.
Dec 12, 2018 Proteus 235 Product Usage: The Proton Therapy System - Proteus 235 (brand... There is a risk of detachment of the Compact Gantry Rolling Floor. Class II Ion Beam Applications S.A.
Jun 27, 2018 Proteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with s... Gantry rotation or proton irradiation can be allowed even if apertures or accessories are not cor... Class II Ion Beam Applications S.A.
May 16, 2018 Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A device ... Correction vector confirmation message is lost if access point is changed after sending the corr... Class II Ion Beam Applications S.A.
Jan 26, 2018 Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam f... When switching from Pencil Beam Scanning treatment mode to Uniform Scanning treatment mode, the t... Class II Ion Beam Applications S.A.
Dec 5, 2017 Proteus 235, Uniform and Pencil Beam Scanning The Proton Therapy System - ... An accessory (range shifter, ridge filter&) can be improperly inserted in snout 300x400 with one... Class II Ion Beam Applications S.A.
Nov 17, 2017 Proteus 235, Proton Therapy System a medical device designed to produce and d... There is a risk of misalignment of the patient when using treatment plans with multiple isocenters. Class II Ion Beam Applications S.A.
Nov 1, 2017 Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 The Proton Ther... The internal configuration of the electrometers and the Real-Time control boards of the Dekimo S... Class II Ion Beam Applications S.A.
Oct 19, 2017 Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X The Proton Therapy ... Range for the same energy could be different depending if the layer is the first layer of the ir... Class II Ion Beam Applications S.A.
Oct 17, 2017 Proteus 235, graphite block 8 IBA identified incorrect screw holes depth in graphite block 8 with respect to the degrader Class II Ion Beam Applications S.A.
Apr 10, 2017 Proton therapy system -Proteus 235 aka Proteus Plus. A medical device desi... A PBS (Pencil Beam Scanning) irradiation may pause for different reasons. After a pause, irradiat... Class II Ion Beam Applications S.A.
Mar 21, 2017 Proteus 235, Proton Therapy System In specific circumstances, the user is able to restart an aborted irradiation without having to s... Class II Ion Beam Applications S.A.
Mar 9, 2017 Proteus 235 The Proton Therapy System can allow gantry rotation even if the snout is not properly locked. Class II Ion Beam Applications S.A.
Feb 9, 2017 Proteus 235 It has been observed during testing that there could be clinically non-negligible amount of dark ... Class II Ion Beam Applications S.A.
Dec 13, 2016 Proteus 235, Proton Therapy System Product Usage: The Proton Therapy Syst... Software issue Class II Ion Beam Applications S.A.
Oct 28, 2016 12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usag... IBA is initiating this recall to address an issue identified with AdaPTinsight software and to re... Class II Ion Beam Applications S.A.
Sep 16, 2016 12C IBA is initiating this recall to notify its customers that the use of non-IBA accessories and/or ... Class II Ion Beam Applications S.A.
Sep 16, 2016 Proteus ONE and Proteus Plus IBA is initiating this recall to notify its customers that the use of non-IBA accessories and/or ... Class II Ion Beam Applications S.A.
Aug 7, 2016 Proteus 235 The PTS is a medical device designed to produce and deliver ... IBA is recalling to provide information through a Safety Notice to reduce risk for maintenance te... Class II Ion Beam Applications S.A.
May 18, 2016 Proteus 235 and Proteus ONE proton therapy systems Recall is being initiated to address on-site software installations not being performed consisten... Class II Ion Beam Applications S.A.
Apr 11, 2016 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteu... IBA is conducting a voluntary recall to address a PTS (Proton Therapy System) software issue and ... Class II Ion Beam Applications S.A.
Nov 7, 2014 adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment room 4: I2C is used wit... Two issues were identified: 1. In the release of adaPT insight v1.3.2., the kV/kV Single Sou... Class II Ion Beam Applications S.A.
Mar 27, 2014 Proteus 235 Proton Therapy System for cancer treatment. While the Proteus 235 is in the pencil beam scanning (PBS) treatment mode, on rare occasions, Low... Class II Ion Beam Applications S.A.
Dec 4, 2013 Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, m... Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculatio... Class II Ion Beam Applications S.A.

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.