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Browse Device Recalls

14 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 14 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 14 FDA device recalls.

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DateProductReasonClassFirm
Feb 1, 2022 Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 3... Malfunction of the hand pendant controlling movement of the therapy couch and nozzle may result i... Class II Mevion Medical Systems, Inc.
Oct 19, 2020 MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage:... Treatment beam information disappears on Treatment Console screen while beam delivery continues p... Class II Mevion Medical Systems, Inc.
Jun 23, 2020 MEVION S250 Proton Radiation Treatment System; intended to deliver proton rad... The perforated screen that divides the inside of the process water tank has a very sharp edge ac... Class II Mevion Medical Systems, Inc.
May 15, 2020 MEVION S250i, MEVION S250; Proton Radiation Treatment System Couch Correction moves sent after using a 3D CT scan are partially lost if the previous correctio... Class II Mevion Medical Systems, Inc.
Oct 1, 2018 MEVION S250i Treatment is allowed to continue (via partials) in situations where dDose1 interlock has tripped Class II Mevion Medical Systems, Inc.
Jun 29, 2018 MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Us... QFix has advised Mevion Medical Systems that they are identifying unauthorized combinations of QF... Class II Mevion Medical Systems, Inc.
Dec 16, 2016 MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy An error can occur causing Delta corrections to be lost when one setup field is closed and anothe... Class II Mevion Medical Systems, Inc.
Oct 31, 2016 MEVION S250 Product Usage: Proton Radiation Therapy Completing Setup Without Program Move Complete Can Cause An Isocenter Error Class II Mevion Medical Systems, Inc.
Oct 21, 2016 MEVION S250 Product Usage: Proton Radiation Therapy System Recovery of Incorrect Isocenter -operational change Class II Mevion Medical Systems, Inc.
Oct 20, 2016 MEVION S250 Product Usage: Proton Radiation Therapy System Software defect:2D projection of contours in Verity. The defect causes structures to appear off f... Class II Mevion Medical Systems, Inc.
Mar 15, 2016 MEVION S250 for Proton Radiation Therapy Possibility of Gantry Motion with Aperture or Compensator only partially inserted. An Aperture m... Class II Mevion Medical Systems, Inc.
Nov 18, 2015 MEVION S250 Radiation therapy system The treatment table positioning belt can slip gear positions, resulting in deviation of patient s... Class II Mevion Medical Systems, Inc.
Nov 10, 2014 MEVION S250, used for proton radiation therapy. Software defect that causes an incorrect dose compensation function to be applied to the internal... Class II Mevion Medical Systems, Inc.
Mar 5, 2014 MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Pr... Geometric positioning error can occur after a rotational correction has been applied to one or mo... Class II Mevion Medical Systems, 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.