Kirwan Surgical Products recalls disposable 25-gauge bipolar surgical pencils (model 14-5011L) due to potential outer tube breakage during eye surgery. Affected items have specific GTINs and expiration dates through 2027.
Potential for the outer stainless-steel tube to break or detach.
Kirwan Surgical Products recalls disposable 25-gauge bipolar surgical pencils (model 14-5011L) because the outer stainless-steel tube might break or detach during use. This could cause injury to patients during delicate eye or soft tissue surgeries.
The outer stainless-steel tube in these surgical pencils might break or detach during use, especially in delicate eye surgeries. This could lead to injury to the patient's tissues or surgical site.
Surgical teams using the Kirwan disposable 25-gauge bipolar pencil (model 14-5011L) for eye or soft tissue procedures are most at risk. Patients undergoing surgery with this device could face injury if the tube breaks.
Check for the model number 14-5011L on the pencil's packaging. The product comes in pouches (GTIN 00841019101056), inner packs (10841019101053), and cases (20841019101050). Expiration dates on these items are through September 1, 2027.
Verify the model number 14-5011L and GTINs on the packaging to confirm if your item is affected.
Reach out to Kirwan Surgical Products for specific guidance on handling affected items.
The outer stainless-steel tube might break or detach during use, which could cause injury to patients during eye or soft tissue surgeries.
Model 14-5011L (disposable 25-gauge bipolar pencil, straight, long).
Check for model number 14-5011L and GTINs: pouch (00841019101056), inner pack (10841019101053), case (20841019101050).
Contact Kirwan Surgical Products for specific guidance on handling affected items.
We’ve drafted a message you can send Kirwan to request your refund or repair — edit it as you like.
Subject: Recall Z-0655-2025 — Kirwan Kirwan Hello, I own a Kirwan that is covered by recall Z-0655-2025 from Kirwan. 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.
