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Browse Device Recalls

8 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 8 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 8 FDA device recalls.

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DateProductReasonClassFirm
Sep 11, 2025 FERNO POWER X2 POWERED AMBULANCE COT, Model/Catalog Number: 0015816; FOR USE ... The fastening post hardware could loosen allowing the fastening post to detach from the cot Class II Ferno-Washington Inc
Oct 7, 2022 FERNO POWER X1 AMBULANCE COT- Item #0015807/UDI-DI 00190790002183 with 36V ... Batteries could become unstable when not properly maintained and/or subjected to repeated drops, ... Class II Ferno-Washington Inc
Mar 8, 2017 Ferno PROFlexx¿ Model 28Z Chair Cot The recall was initiated as a result of the detection of an incorrect nut used in manufacturing. Class II Ferno-Washington Inc
Mar 10, 2016 Poly-bags containing the strap labeled with "Adult" sticker. Each strap ki... On March 9, 2016, the firm was contacted regarding the possibility of incorrect labeling on the o... Class II Ferno-Washington Inc
Mar 10, 2016 Poly-bags containing splint strap labeled with "Pediatric" sticker. Each s... On March 9, 2016, the firm was contacted regarding the possibility of incorrect labeling on the o... Class II Ferno-Washington Inc
Aug 3, 2015 Ferno iNX Wheeled Stretcher, Integrated Patient Transport & Loading System ... Hole elongation in the telescoping load frame channel. A hole elongation could affect the ability... Class II Ferno-Washington Inc
May 1, 2015 Wheel caster set screw for Ferno iNX Wheeled Stretcher. Ferno iNX Wheeled St... The firm discovered an improperly installed set screw in one caster arm assembly on a unit in pro... Class II Ferno-Washington Inc
Dec 3, 2014 Ferno Model 35X PROFlexx Stretchers, one unit per package The wheel castor assemblies may be loosening on the stretchers. Class II Ferno-Washington 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.