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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
Sep 11, 2020 Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Produc... The magnet located inside the foot pedal may come off and may result in unattended start of unsto... Class II Bien-Air Surgery Sa
Sep 11, 2020 Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Us... The magnet located inside the foot pedal may come off and may result in unattended start of unsto... Class II Bien-Air Surgery Sa
Sep 11, 2020 Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: i... The magnet located inside the foot pedal may come off and may result in unattended start of unsto... Class II Bien-Air Surgery Sa
Sep 11, 2020 Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product U... The magnet located inside the foot pedal may come off and may result in unattended start of unsto... Class II Bien-Air Surgery Sa
Sep 11, 2020 Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Pr... The magnet located inside the foot pedal may come off and may result in unattended start of unsto... Class II Bien-Air Surgery Sa

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.