FDA Device recall Z-1954-2025
Brand Name: Tecfen Medical Product Name: 2.0mm Crescent Knife Angled Bevel Up Model/Catalog Number: QKN1010 Software Version: No software P…
- FDA Device
- Class II
- ongoing
- Published 2025-06-18
On 2025-06-18 the FDA classified a Class II recall of Brand Name: Tecfen Medical Product Name: 2.0mm Crescent Knife Angled Bevel Up Model/Catalog Number: QKN1010 Software Version: No software P… by Tecfen Medical, citing sterility assurance for Ophthalmic knives.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1954-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-25 |
| Published | 2025-06-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Tecfen Medical |
| Distribution | US |
Product
Brand Name: Tecfen Medical Product Name: 2.0mm Crescent Knife Angled Bevel Up Model/Catalog Number: QKN1010 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile and packaged individually in Tyhvek 1059B. The crescent knife is used to create smooth, curved incisions for corneal transplant procedures, used in small incision cataract surgery and phacoemulsification to create self-sealing scleral tunnels, used for creating tunnel incisions in the sclera and cornea during procedures like trabeculectomy. Component: No
Reason
Sterility assurance for Ophthalmic knives.
Identifiers
| code_info | Lot Code: Manufacture date: 2024-11-22 Expiration date: 2027-11-21 Lot number: ZGY24071501-03 UDI: 00817618021330 |
|---|
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-1954-2025%22
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