Kirwan Surgical Products, LLC: Device Recall

Recall #Z-0660-2025 · 11/14/2024

Class I: Dangerous

Recall Details

Recall Number
Z-0660-2025
Classification
Class I
Product Type
Device
Recalling Firm
Kirwan Surgical Products, LLC
Status
Ongoing
Date Initiated
11/14/2024
Location
Marshfield, MA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,999 units

Reason for Recall

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

Product Description

Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011. 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.

Distribution Pattern

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.

Other Recalls by Kirwan Surgical Products, LLC

View all recalls by Kirwan Surgical Products, LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.