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Browse Device Recalls

5 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5 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 5 FDA device recalls.

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DateProductReasonClassFirm
May 24, 2024 WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation flu... Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set... Class II WOM World Of Medicine AG
Jul 17, 2023 Aquilex Fluid Control System-Intended to provide fluid distension of the uter... The display of inflow volume can reach its limit of 30,000 ml during long procdeure and the inflo... Class II WOM World Of Medicine AG
Jun 18, 2021 Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000 When the display of inflow volume to the uterus reaches 32450 ml, the fluid management system con... Class II WOM World of Medicine AG
Aug 14, 2019 Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Pr... The deficit displayed by the pump can differ from the real deficit, leading potentially to patien... Class II WOM World of Medicine AG
Oct 22, 2018 PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flo... It is possible that the packaging of the product can be damaged by the prongs on the tube set. Class II WOM World of Medicine AG

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.