The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0657-2025·Announced 2024-12-25

Ambler Surgical Bipolar Pencil recalled for outer tube structural failure

Kirwan Surgical Products is recalling the Ambler Surgical Bipolar Pencil 25 Gauge Straight (Model PD7226) because the outer stainless-steel tube may break or detach during use. 4,470 units worldwide are affected.

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: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Potential for the outer stainless-steel tube to break or detach."

Plain-English summary

Kirwan Surgical Products, LLC is recalling the Ambler Surgical Bipolar Pencil 25 Gauge Straight, Model PD7226. The device is a disposable microsurgical pencil designed for use in eye surgery and other soft tissue procedures, such as cauterization of the retinal area during surgical operations.

The recall is due to a potential defect in which the outer stainless-steel tube may break or detach during use. If the tube becomes compromised during surgery, it could affect the procedure's safety and effectiveness.

Approximately 4,470 units are affected by this recall. Distribution was worldwide, including throughout the United States and Puerto Rico, as well as 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.

If you have received or are using this device, stop using it immediately. Contact Kirwan Surgical Products, LLC for information about obtaining a replacement or refund.

The recalled product

Product
Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226. 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 of the retinal area…
Manufacturer
Kirwan Surgical Products, LLC
Category
Medical Device — Surgical instrument
Hazard
Affected units
4,470

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 (1)

  • Model/Catalog Number: PD7226. GTINs: Pouch - 00190660001025

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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