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Browse Device Recalls

3 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3 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 3 FDA device recalls.

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DateProductReasonClassFirm
Oct 14, 2022 GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Sin... Procedure Instruments with erroneous unit carton labels. Class II Sonendo Inc
Oct 14, 2022 GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02 Procedure Instruments with erroneous unit carton labels. Class II Sonendo Inc
Oct 23, 2019 GENTLEWAVE REF: FG-002-0001 The console would continue to run for extended period when the foot pedal was released. Class II Sonendo 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.