The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0659-2025·Announced 2024-12-25

Nidek Disposable Bipolar Pencil Surgical Instruments Recalled for Tube Breakage Risk

Kirwan Surgical Products recalls Nidek Disposable Bipolar Pencil surgical instruments due to risk that the stainless-steel tube may break or detach during procedures.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I medical device recall. The agency classification establishes a minimum severity of 4. While no injuries or deaths have been reported, the structural failure risk (tube breakage or detachment) during surgical procedures poses serious potential harm to patients and surgical staff.

Plain-English summary

Kirwan Surgical Products, LLC is recalling 925 units of the Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight (Model 18241-0979), a surgical instrument used in eye surgery and soft tissue procedures, including retinal cauterization. The outer stainless-steel tube on these devices may break or detach during surgical use.

The affected devices are marked with expiration dates on or after September 1, 2027. These instruments were distributed worldwide to surgical facilities throughout the United States and Puerto Rico, and internationally to Australia, Canada, Denmark, France, Germany, Italy, Japan, Mexico, Netherlands, Philippines, South Africa, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and Venezuela.

Healthcare providers should immediately cease use of this device and contact Kirwan Surgical Products regarding inventory management. Patients who underwent procedures using this device should consult their healthcare provider with any questions about their surgical care.

The recalled product

Product
Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: 18241-0979. 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…
Manufacturer
Kirwan Surgical Products, LLC
Category
Medical Device — Surgical Instrument
Hazard
Affected units
925

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 (2)

  • Model/Catalog Number: 18241-0979. GTINs: Pouch - 00841019116623
  • Inner Pack - 10841019116620

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 →

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