The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0656-2025·Announced 2024-12-25

Surgical Bipolar Pencil Recall: Risk of Tube Breakage During Eye Surgery

Kirwan Surgical Products is recalling disposable bipolar surgical pencils used in eye surgery because the outer stainless-steel tube may break or detach during use.

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 is an FDA Class I recall, which mandates a minimum severity score of 4. The potential structural failure of a surgical instrument used in delicate eye surgery procedures creates significant risk, although no injuries have been reported.

Plain-English summary

Kirwan Surgical Products, LLC is recalling disposable microsurgical bipolar pencils (Model AB-7004) that are designed for use in eye surgery and other soft tissue surgical procedures, including cauterization of the retinal area.

The recall was initiated due to a potential for the outer stainless-steel tube to break or detach during use. Such a structural failure could compromise the integrity of the surgical instrument during delicate procedures.

Approximately 800 units have been distributed worldwide, including to the United States and Puerto Rico, as well as to 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. All units with expiration dates from September 1, 2027 onward are affected.

Healthcare providers and facilities that have received this product should contact Kirwan Surgical Products for further instructions and guidance regarding the recall.

The recalled product

Product
Accutome/Microsurgical Disposable Bipolar Pencil 5 in. (12.7cm) 25 Gauge Straight. Model/Catalog Number: AB-7004 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 Instruments
Hazard
Affected units
800

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: AB-7004. GTINs: Pouch - 00841019113875
  • Inner Pack - 10841019113872

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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