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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
Jan 3, 2025 Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000... Their is a potential that implanted pulse generators may stop delivering therapy due to an intern... Class II LivaNova USA, Inc.
Jan 3, 2025 Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/... Their is a potential that implanted pulse generators may stop delivering therapy due to an intern... Class II LivaNova USA, Inc.
Dec 12, 2024 SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburs... Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanicall... Class II LivaNova USA, Inc.
Dec 12, 2024 SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Ther... Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanicall... Class II LivaNova USA, Inc.
Dec 2, 2021 Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Mode... A manufacturing issue may cause the silicone tubing wall thickness of vagus nerve stimulation lea... Class II LivaNova USA, 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.