Recall Z-0658-2025— Kirwan Surgical Products, LLC

Name: FDA recall Z-0658-2025
Creator: U.S. Food and Drug Administration
Published: 2024-11-14

Class I · Ongoing

Class I FDA medical device recall by Kirwan Surgical Products, LLC, initiated 2024-11-14. It names one FDA 510(k) clearance: K864402. Product: Walcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011. 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.. Reason: Potential for the outer stainless-steel tube to break or detach..

Recalling firm: Kirwan Surgical Products, LLC
Classification: Class I
Status: Ongoing
Initiated: 2024-11-14
Firm location: Marshfield, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K864402 — BIPOLAR ELECTROSURGICAL INTRAOCULAR PROBENew England Surgical Instrument Corp.·cleared 1987-01-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Walcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011. 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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.