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Browse Device Recalls

6 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 6 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 6 FDA device recalls.

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DateProductReasonClassFirm
Mar 9, 2023 DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1... The instruction manual is being replaced with an updated version that is in alignment with labeli... Class II DeVilbiss Healthcare LLC
Nov 18, 2022 DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q The firm has received complaints of the device becoming hot. The firm has updated the user manual... Class II DeVilbiss Healthcare LLC
Sep 19, 2022 125 series iGO2 Portable Oxygen Concentrator-indicated for the administratio... An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patie... Class II DeVilbiss Healthcare LLC
May 23, 2016 DeVilbiss Model 7305P-D Powered Suction Unit A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature fai... Class II DeVilbiss Healthcare LLC
May 13, 2014 DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep... A limited number of DV5x Series CPAP units were manufactured and shipped without the serial numbe... Class III DeVilbiss Healthcare LLC
Mar 7, 2013 DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 8... End users of the DeVilbiss Disposable Suction Container/Filter had exposed the bacterial filter c... Class II DeVilbiss Healthcare LLC

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.