The Recall Desk
SevereFDA (Devices)·Z-0660-2025·Announced 2024-12-25

Optikon Bipolar Pencil surgical tool recalled for tube failure risk

FDA recalls Kirwan Surgical's Optikon Bipolar Pencil surgical instruments due to risk that the outer stainless-steel tube may break or detach during use. The recalled devices were distributed worldwide.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall, which mandates a minimum Severe classification. The hazard—potential breakage or detachment of the outer tube during surgery—could compromise the surgical procedure. Although no injuries have been reported, the agency classification and risk-of-harm nature of the surgical instrument justify a Severe severity level.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling the Optikon Bipolar Pencil 25 Gauge Straight (Model OPT14-5011), a disposable microsurgical device manufactured by Kirwan Surgical Products, LLC. The device is designed for use in eye surgery and other soft tissue procedures, including cauterization of the retinal area during surgical operations.

The recall was initiated due to a potential defect in the outer stainless-steel tube. The tube may break or detach during use, which could compromise the surgical procedure and potentially cause harm to the patient.

Approximately 2,999 units of the affected device have been distributed worldwide, including across the United States and Puerto Rico, as well as internationally to Australia, Canada, Chile, Colombia, Denmark, Egypt, England, France, Germany, Israel, Italy, Japan, Mexico, Netherlands, Philippines, South Africa, Switzerland, Taiwan, Thailand, Trinidad, Turkey, United Arab Emirates, and Venezuela. The affected lot codes are: 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, and J30100-01.

Healthcare facilities and providers who have received these devices should cease use immediately and contact Kirwan Surgical Products, LLC, or the FDA with any questions or to report any adverse events.

The recalled product

Product
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 r
Manufacturer
Kirwan Surgical Products, LLC
Category
Medical Device — Surgical Instrument
Hazard
Affected units
2,999

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (15)

  • 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.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 7 recalled by Kirwan Surgical Products, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Related recalls

Same manufacturer · Kirwan Surgical Products, LLC

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