# FDA recall Z-0654-2025

> **Kirwan Surgical Products, LLC** · Class I · device recall initiated 2024-11-14.

## Product

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.

## Reason for recall

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

## 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.

## Key facts

- **Recall number:** Z-0654-2025
- **Recalling firm:** Kirwan Surgical Products, LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-14
- **Report date:** 2024-12-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marshfield, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0654-2025

## Citation

> AI Analytics. FDA recall Z-0654-2025. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0654-2025. Source: US FDA. Licensed CC0.

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