Kirwan Surgical recalls Optikon Bipolar Pencil 25 Gauge Straight (model OPT14-5011) due to potential outer stainless-steel tube breakage during eye surgery. Affected units have specific lot codes.
Potential for the outer stainless-steel tube to break or detach.
Kirwan Surgical is recalling their Optikon Bipolar Pencil 25 Gauge Straight surgical tool because the outer stainless-steel tube might break or detach during use. This could lead to complications in delicate eye or soft tissue procedures if the tube separates.
The outer stainless-steel tube in the pencil could break or detach during surgical procedures. This might cause the device to malfunction or become a hazard during delicate eye or soft tissue surgeries, potentially leading to complications for the patient.
Surgical professionals using the Optikon Bipolar Pencil 25 Gauge Straight for eye or soft tissue procedures are most at risk. Patients undergoing surgery with this device may face complications if the tube breaks during the procedure.
Check for the model number OPT14-5011 on the product. Affected units have specific lot codes including J20499-01 through J30100-01. The product is a disposable microsurgical bipolar pencil used in eye surgery.
Identify the model number (OPT14-5011) and lot codes (J20499-01 to J30100-01) to confirm if your device is affected.
The outer stainless-steel tube could break or detach during use, which might cause complications in delicate eye or soft tissue surgeries.
Check the model number and lot codes to see if your device is affected. If it is, contact Kirwan Surgical for further instructions.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Kirwan Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0660-2025 — Kirwan Surgical Kirwan Surgical Hello, I own a Kirwan Surgical that is covered by recall Z-0660-2025 from Kirwan Surgical. 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.
