Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil — Class I medical device recall Z-0654-2025
Ongoing recall by Kirwan Surgical Products, LLC, reported 2024-12-25, distributed nationwide. Potential for the outer stainless-steel tube to break or detach.
| Recall number | Z-0654-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Kirwan Surgical Products, LLC, Marshfield, MA, United States |
| Recall initiated | 2024-11-14 |
| Classified | 2024-12-16 |
| Reported by FDA | 2024-12-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, CA, CH, CL, CO, DE, DK, EG, FR, GB, IL, IT, JP, MX, NL, PH, TH, TR, TT, TW, VE, ZA |
| Quantity | 80,060 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00841019101049, 10841019101046, 20841019101043 |
| Model numbers | 14-5011 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0654-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.