Kirwan Surgical Products recalls disposable 25-gauge bipolar surgical pencils (model 14-5011) due to potential outer steel tube breaking or detaching during eye surgery. Affected units sold from 2022-09-06 to 2024-10-02 with expiration dates through 2027-09-01.
Potential for the outer stainless-steel tube to break or detach.
Kirwan Surgical Products is recalling disposable 25-gauge bipolar surgical pencils (model 14-5011) because the outer stainless-steel tube might break or detach during use. This could pose a risk of injury to patients during delicate eye or soft tissue surgeries.
The outer stainless-steel tube could break or detach during surgical procedures, potentially causing injury to patients. This is especially concerning for delicate eye surgeries where precise control is critical. The risk occurs during normal use when the pencil is being used for cauterization.
Surgical teams using the Kirwan Disposable 25-gauge bipolar pencil (model 14-5011) for eye or soft tissue procedures are most at risk. The product was sold to hospitals and surgical centers from September 2022 through October 2024.
Check for the model number 14-5011 on the packaging. The product was sold from September 2022 to October 2024 with expiration dates through September 1, 2027.
Verify the model number on the packaging to confirm if it's 14-5011.
Reach out to Kirwan Surgical Products for specific instructions on handling the recalled item.
The recall indicates a potential risk of the outer tube breaking or detaching during use, so it's not safe to use without checking the recall status.
Look for the model number 14-5011 on the packaging. The product was sold from September 2022 to October 2024 with expiration dates through September 1, 2027.
Contact Kirwan Surgical Products directly for specific instructions on handling the recalled item.
We’ve drafted a message you can send Kirwan Surgical Products to request your refund or repair — edit it as you like.
Subject: Recall Z-0654-2025 — Kirwan Surgical Products Kirwan Surgical Products Hello, I own a Kirwan Surgical Products that is covered by recall Z-0654-2025 from Kirwan Surgical Products. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
