Browse Device Recalls

7 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 7 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 7 FDA device recalls.

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DateProductReasonClassFirm
Nov 14, 2024 Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Mo... Potential for the outer stainless-steel tube to break or detach. Class I Kirwan Surgical Products, LLC
Nov 14, 2024 Accutome/Microsurgical Disposable Bipolar Pencil 5 in. (12.7cm) 25 Gauge Stra... Potential for the outer stainless-steel tube to break or detach. Class I Kirwan Surgical Products, LLC
Nov 14, 2024 Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: ... Potential for the outer stainless-steel tube to break or detach. Class I Kirwan Surgical Products, LLC
Nov 14, 2024 Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD722... Potential for the outer stainless-steel tube to break or detach. Class I Kirwan Surgical Products, LLC
Nov 14, 2024 Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Lo... Potential for the outer stainless-steel tube to break or detach. Class I Kirwan Surgical Products, LLC
Nov 14, 2024 Walcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011. ... Potential for the outer stainless-steel tube to break or detach. Class I Kirwan Surgical Products, LLC
Nov 14, 2024 Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011. ... Potential for the outer stainless-steel tube to break or detach. Class I Kirwan Surgical Products, LLC

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.