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Browse Device Recalls

8 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 8 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 8 FDA device recalls.

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DateProductReasonClassFirm
Nov 4, 2019 Apollo, Model Numbers 9784100231, 9784120131, 9784130131 - Product Usage: Apo... An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the an... Class II Villa Sistemi Medicali S.P.A.
Nov 4, 2019 Apollo DRF, Model Number 9784220831 - Product Usage: The remote controlled ta... An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the an... Class II Villa Sistemi Medicali S.P.A.
Nov 4, 2019 Apollo EZ, Model Number 9784152036 - Product Usage: The Apollo EZ remote-cont... An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the an... Class II Villa Sistemi Medicali S.P.A.
Nov 4, 2019 Juno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray ... An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the an... Class II Villa Sistemi Medicali S.P.A.
Dec 27, 2016 Apollo EZ; Model: 9784152036 Product Usage: General, multi-function x-ray... Patient fell from the table because the footrest of the device detached from the table top while ... Class II Villa Sistemi Medicali S.P.A.
Dec 27, 2016 Apollo DRF; Model: 9784220831 Product Usage: General, multi-function x-ra... Patient fell from the table because the footrest of the device detached from the table top while ... Class II Villa Sistemi Medicali S.P.A.
Dec 27, 2016 Apollo; Models: 9784000131 9784000231 9784020131 9784020231 9784100231 9... Patient fell from the table because the footrest of the device detached from the table top while ... Class II Villa Sistemi Medicali S.P.A.
Dec 27, 2016 Juno DRF; Model: 709020 Product Usage: General, multi-function x-ray syst... Patient fell from the table because the footrest of the device detached from the table top while ... Class II Villa Sistemi Medicali S.P.A.

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.