Kirwan Surgical Products, LLC recalls Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: 18241-0979. Product Description: The Dis

Recalled December 25, 2024 · FDA recall Z-0659-2025 · Kirwan Surgical Products

Hazard

Potential for the outer stainless-steel tube to break or detach. · FDA Class I

Units

925 units

Sold at

Worldwide - US Nationwide including PUERTO RICO; 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.

Description

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

Product

Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: 18241-0979. Product Description: 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.

Manufacturer(s)

Kirwan Surgical Products, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →