FDA Device recall Z-0654-2025
Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight
- FDA Device
- Class I
- ongoing
- Published 2024-12-25
On 2024-12-25 the FDA classified a Class I recall of Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight by Kirwan Surgical Products, citing potential for the outer stainless-steel tube to break or detach.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0654-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-11-14 |
| Published | 2024-12-25 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Kirwan Surgical Products |
| Distribution | US |
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
Potential for the outer stainless-steel tube to break or detach.
Identifiers
| code_info | Model/Catalog Number: 14-5011. GTINs: Pouch - 00841019101049, Inner Pack - 10841019101046, Case - 20841019101043. Ste…Model/Catalog Number: 14-5011. GTINs: Pouch - 00841019101049, Inner Pack - 10841019101046, Case - 20841019101043. Sterile Lot Range: 220906 to 241002. All expiration dates from 2027-09-01(YYYY-MM_DD) on would encompass the for the recall. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0654-2025%22
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