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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.

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DateProductReasonClassFirm
Feb 16, 2023 thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc. thermage RF G... A service unit was potentially improperly tested and calibrated during manufacturing on a failed ... Class II Solta Medical Inc
Dec 30, 2019 Thermage Face Tip 3.0, REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377; REF T... Complaints of sparking of the tips of the electrosurgical device used in RF surgical procedures. ... Class II Solta Medical Inc
Jun 1, 2017 VASER PRO Amplifier, VASER 2.2 VASERlipo System stem, Rx Only, 115/230V - 60/... Potential inaccurate calibration by service depot repair, which could contribute to patients bein... Class II Solta Medical Inc
Jun 1, 2017 VASER Amplifier, VASER 2.2 VASERlipo System, Rx Only, 115/230V - 60/50Hz 300V... Potential inaccurate calibration by service depot repair, which could contribute to patients bein... Class II Solta Medical 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.