Class I — Kirwan Surgical Products, LLC
| Recalling firm | KIRWAN SURGICAL PRODUCTS LLC |
|---|---|
| Registered facility | KIRWAN SURGICAL PRODUCTS, LLC. (the firm's only registered facility) |
| Classification | Class I |
| Status | Ongoing |
| Reason | Potential for the outer stainless-steel tube to break or detach. |
| Product | Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226. 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. Component: No |
| Quantity | 4,470 units |
| 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. |
| Initiated | 2024-11-14 |
| Classified | 2024-12-16 |
| Recall number | Z-0657-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Kirwan Surgical Products, LLC (Z-0657-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95753/
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