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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
Mar 14, 2025 DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002) Potential of compromised compatibility resulting in influence on the positioning of the reference... Class II Pro-Med Instruments Gmbh
Jul 5, 2018 DORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest ... The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional ... Class I Pro-Med Instruments Gmbh
Jul 5, 2018 DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percuta... The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional ... Class I Pro-Med Instruments Gmbh
Jul 5, 2018 DORO LUCENT Transitional Member, REF 1101.026 Component of headrest system ... The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional ... Class I Pro-Med Instruments Gmbh
Nov 2, 2017 pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 ... The firm received reports of two breakages of the pin tips which occurred during two identical su... Class II Pro-Med Instruments 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.