Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil Recalled by Kirwan Surgical Products, LLC Due to Potential for the outer stainless-steel tube to break...

Date: November 14, 2024
Company: Kirwan Surgical Products, LLC
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Kirwan Surgical Products, LLC directly.

Affected Products

Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Long. Model/Catalog Number: 14-5011L 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 during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip outer diameter is 25 gauge.

Quantity: 66 units

Why Was This Recalled?

Potential for the outer stainless-steel tube to break or detach.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Kirwan Surgical Products, LLC

Kirwan Surgical Products, LLC has 7 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report