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Browse Device Recalls

4 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4 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 4 FDA device recalls.

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DateProductReasonClassFirm
May 7, 2024 CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intend... CORI Surgical System with Real Intelligence Software exhibits an increased Marker Registration Er... Class II Blue Belt Technologies, Inc
Nov 13, 2023 CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S Possibility that the user is unable to resolve drill disconnection error messages. Class II Blue Belt Technologies, Inc
Sep 7, 2023 Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software ve... CORI software was missing a planning stage that appears in cases of significant knee deformation ... Class II Blue Belt Technologies, Inc
Jul 19, 2013 Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile... Blue Belt Technologies is recalling sterile Monitor Drapes used with their Navio PFS system durin... Class II Blue Belt Technologies MN

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.