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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
Mar 28, 2023 YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileR Optical Trocars sterility assurance can not be guaranteed Class II Surgical Innovations Ltd
Mar 28, 2023 YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR Optical Trocars sterility assurance can not be guaranteed Class II Surgical Innovations Ltd
Jan 20, 2022 Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; Yell... Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile. Class II Surgical Innovations Ltd
Jan 20, 2022 Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in lapar... Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile. Class II Surgical Innovations Ltd

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.