The Recall Desk
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.

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 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
  • structural-defect
  • mechanical-failure

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.

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