The Recall Desk
SevereFDA (Devices)·Z-0655-2025·Announced 2024-12-25

Kirwan Surgical Bipolar Pencil Recalled Due to Potential Tube Breakage

Kirwan Surgical Products is recalling its Disposable 25-gauge Bipolar Pencil (Model 14-5011L) because the outer stainless-steel tube may break or detach during use. The defect could create a safety hazard during eye surgery and other soft tissue procedures.

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. FDA Class I recalls require a minimum severity score of 4 per recall guidance. Although no deaths or serious injuries have been reported, the Class I designation reflects a reasonable probability of serious adverse health consequences from structural failure of a surgical instrument during use.

Plain-English summary

Kirwan Surgical Products LLC is recalling its Disposable 25-gauge Bipolar Pencil, Model 14-5011L, a surgical instrument designed for eye surgery and other soft tissue procedures, including cauterization of the retinal area. The product has a molded handle with a 25-gauge outer diameter tip.

The outer stainless-steel tube of the pencil may break or detach during surgical use. This potential structural failure creates a safety hazard during procedures.

A total of 66 units with sterile Lot Number 221020 were distributed worldwide, including to the United States, Puerto Rico, Australia, Canada, Chile, Colombia, Denmark, Egypt, England, France, Germany, Israel, Italy, Japan, Mexico, the Netherlands, the Philippines, South Africa, Switzerland, Taiwan, Thailand, Trinidad, Turkey, the United Arab Emirates, and Venezuela. The recalled lot includes all units with expiration dates of September 1, 2027 or later.

The recalled product

Product
Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Long. Model/Catalog Number: 14-5011L The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauteri
Manufacturer
Kirwan Surgical Products, LLC
Category
Medical Device — Surgical / Electrosurgical
Hazard
  • breakage
  • detachment

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: 14-5011L. GTINs: Pouch - 00841019101056
  • Inner Pack - 10841019101053

Distribution

Distributed nationwide across the United States.

Related recalls

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