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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
Apr 18, 2024 Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545,... A small number of devices may have a higher probability of a crack within the internal electronic... Class II MED-EL Elektromedizinische Gereate, Gmbh
Oct 16, 2018 MED EL Cochlear Implant System, PULSARci100 Standard - Product Usage: The PUL... Devices were distributed despite the Helium-fine leak test results not being within the cochlear ... Class II MED-EL Elektromedizinische Gereate, Gmbh
Oct 16, 2018 MED EL Cochlear Implant System, SONATATIi100, sold under the following implan... Devices were distributed despite the Helium-fine leak test results not being within the cochlear ... Class II MED-EL Elektromedizinische Gereate, Gmbh
Oct 16, 2018 MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the follo... Devices were distributed despite the Helium-fine leak test results not being within the cochlear ... Class II MED-EL Elektromedizinische Gereate, Gmbh
Oct 25, 2016 SONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery Pack Ca... Unit Defect: Firm inspection revealed units did not have the compartment lock firmly welded to th... Class II MED-EL Elektromedizinische Gereate, Gmbh

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.