FDA Device recall Z-0659-2025
Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight
- FDA Device
- Class I
- ongoing
- Published 2024-12-25
On 2024-12-25 the FDA classified a Class I recall of Nidek Co. Disposable Bipolar Pencil 25 Gauge 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-0659-2025 |
| 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
Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: 18241-0979. 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.
Identifiers
| code_info | Model/Catalog Number: 18241-0979. GTINs: Pouch - 00841019116623, Inner Pack - 10841019116620, Case - 20841019116627. Al…Model/Catalog Number: 18241-0979. GTINs: Pouch - 00841019116623, Inner Pack - 10841019116620, Case - 20841019116627. 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-0659-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.