The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0654-2025·Announced 2024-12-25

Kirwan Surgical Disposable Bipolar Pencils recalled for potential tube failure

Kirwan Surgical Products is recalling 80,060 Disposable Bipolar Pencils (Model 14-5011) because the outer stainless-steel tube may break or detach during surgical use. The devices were distributed worldwide.

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: This recall is classified as FDA Class I due to the potential for device component failure during surgical use. Although no reported illnesses or injuries have been documented, Class I medical device recalls inherently warrant a severe rating due to the serious nature of structural failure in surgical instruments.

Plain-English summary

Kirwan Surgical Products, LLC is recalling 80,060 units of the Disposable 25-gauge Bipolar Pencil, Model 14-5011, a surgical instrument designed for use in eye surgery and soft tissue procedures, including retinal cauterization.

The recalled devices have the potential for the outer stainless-steel tube to break or detach during use. This defect affects products with sterile lot numbers from 220906 to 241002 and expiration dates of September 1, 2027 or later.

The devices were distributed worldwide, including throughout the United States and Puerto Rico, as well as 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. Healthcare facilities should discontinue use of affected devices immediately.

The recalled product

Product
Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Model/Catalog Number: 14-5011 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…
Manufacturer
Kirwan Surgical Products, LLC
Category
Medical Device — Surgical Instrument
Hazard
Affected units
80,060

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: 14-5011. GTINs: Pouch - 00841019101049
  • Inner Pack - 10841019101046

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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