The Recall Desk
HighFDA (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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The FDA classified this as a Class I recall, indicating serious potential for adverse health consequences. However, no illnesses or injuries have been reported; the hazard is a potential structural failure without confirmed harm. Per the severity rubric, such cases score 3 (High).

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 durin
Manufacturer
Kirwan Surgical Products, LLC
Category
Medical Device — Surgical instrument
Hazard
  • structural-failure
  • device-malfunction

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.

Related recalls

Same category