Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip outer diameter is 25 gauge.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model/Catalog Number: OPT14-5011. Lot Code: J20499-01, J21637-01, J21999-01, J21995-01, J22003-01, J23738-01, J23739-01, J23740-01, J23743-01, J24697-01, J24710-01, J24711-01, J26812-01, J30100-01. Component, no UDI held by Kirwan Surgical Products.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Kirwan Surgical Products, LLC
- Reason for Recall:
- Potential for the outer stainless-steel tube to break or detach.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip outer diameter is 25 gauge.
Product Codes/Lot Numbers:
Model/Catalog Number: OPT14-5011. Lot Code: J20499-01, J21637-01, J21999-01, J21995-01, J22003-01, J23738-01, J23739-01, J23740-01, J23743-01, J24697-01, J24710-01, J24711-01, J26812-01, J30100-01. Component, no UDI held by Kirwan Surgical Products.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0660-2025
Related Recalls
Potential for the outer stainless-steel tube to break or detach.
Potential for the outer stainless-steel tube to break or detach.
Potential for the outer stainless-steel tube to break or detach.