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Browse Device Recalls

4 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4 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 4 FDA device recalls.

Clear
DateProductReasonClassFirm
Dec 8, 2021 R82 by ETAC Push Brace for High-Low The chrome surface of the push brace can crack during use, potentially cutting the user. Class II R82 A/S
Mar 6, 2020 Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Ra... The plastic plug on the chest support for Mustang and Rabbit/Rabbit Up can come loose without use... Class II R82 A/S
Mar 28, 2019 Wombat Living, Size 3, Item Numbers: 953121-00, 953126-00, 953131-00, 9531... Firm received feedback form the market regarding breakage of the plastic joint which connects the... Class II R82 A/S
Jun 30, 2017 Heron toilet and bath chair Model 880505-01 & 880505-11 Replacement campaign on all units that have a gas spring head in aluminum. Class II R82 A/S

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.