Medical Device Recall: Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Model/Catalog Number: 14-5011 The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other s
Kirwan Surgical Products, LLC · November 14, 2024
Reason for Recall
Potential for the outer stainless-steel tube to break or detach.
Product Description
Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Model/Catalog Number: 14-5011 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
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.
States Affected
NATIONWIDE
Quantity Affected
80,060 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0654-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.