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Browse Device Recalls

9 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 9 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 9 FDA device recalls.

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DateProductReasonClassFirm
May 12, 2020 Type S Extension For use with Varian, CIVCO, Prescription Only - Product Usag... Potential for disengagement of the Varian Style Type-S Extension during patient repositioning. T... Class II Med Tec Inc
Apr 15, 2019 CIVCO Solstice(TM) SRS Immobilization System, Part Numbers: a) CHS03, b) CHS... There is a potential for movement of the Solstice Tilting Head Fixation System during patient set... Class II Med Tec Inc
Nov 8, 2017 Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0, MT6XSM1... When an error message remains displayed and is not cleared in the Protura software with the Elekt... Class II Med Tec Inc
Aug 10, 2017 CIVCO Arm Support, REF 106047, distributed as: (a) Rigid Arm Support, Large,... Rigid Arm Supports (PN: 106015 and 106047), which were used as part of the Posiboard-2 and Posir... Class II Med Tec Inc
Aug 10, 2017 CIVCO Arm Support, REF 106015, distributed as: (a) Rigid Arm Support, Stan... Rigid Arm Supports (PN: 106015 and 106047), which were used as part of the Posiboard-2 and Posir... Class II Med Tec Inc
Mar 31, 2016 Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.... When using the recalled product in split shift mode, the non-sub-millimeter positioning has been ... Class II Med Tec Inc
Aug 19, 2015 CIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070, packag... The wrist straps used for positioning the patient are too long Class II Med Tec Inc
Dec 11, 2014 Civco, MTSR03 Shoulder Retractor with Wrist Loops Kit with Base, plus two pai... The product (wool wrist loop) was manufactured 7cm shorter than product specifications. Class II Med Tec Inc
Dec 11, 2014 Civco, MTSR02 Shoulder Retractor with Sherpa Wrist Loops Kit with Base, Non-s... The product (wool wrist loop) was manufactured 7cm shorter than product specifications. Class II Med Tec 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.