Approximately 92,330 disposable 25-gauge bipolar pencils manufactured by Kirwan Surgical Products, LLC are being recalled. These microsurgical instruments, which are used for cauterization during eye surgery and other soft tissue procedures, include models sold under brands such as Accutome, Ambler Surgical, Walcott, Nidek Co., and Optikon. The recall was initiated because the outer stainless-steel tube on the pencil's tip may break or detach during use. No injuries have been reported in connection with this issue.
If the stainless-steel tube on the surgical pencil breaks or detaches during a procedure, it could lead to surgical delays or injury to the patient's delicate eye or soft tissues.
Quantity: 80,060 units
Quantity: 66 units
Quantity: 800 units
Quantity: 4,470 units
Quantity: 3,010 units
Quantity: 925 units
Quantity: 2,999 units. Component, no UDI held by Kirwan Surgical Products.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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