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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
Jun 9, 2022 CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000 Executing a voluntary discontinuation and removal of parallel plate applicators due to an increas... Class II Zeltiq Aesthetics, Inc
Jun 9, 2022 CoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000 Executing a voluntary discontinuation and removal of parallel plate applicators due to an increas... Class II Zeltiq Aesthetics, Inc
Jun 9, 2022 CoolCurve ZELTIQ Vaccum Applicator REF BRZ-AP1-062-000 Executing a voluntary discontinuation and removal of parallel plate applicators due to an increas... Class II Zeltiq Aesthetics, Inc
Jun 9, 2022 CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000 Executing a voluntary discontinuation and removal of parallel plate applicators due to an increas... Class II Zeltiq Aesthetics, Inc
Jun 9, 2022 CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000 Executing a voluntary discontinuation and removal of parallel plate applicators due to an increas... Class II Zeltiq Aesthetics, Inc
Jul 5, 2021 CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW releas... An incorrect error messaging system that could potentially lead to: 1) Reporting a thermal event ... Class II Zeltiq Aesthetics, 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.