FDA Device recall Z-1949-2025
Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog Number: QKN1501 Software Version: No software Product Descripti…
- 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: 15 degree Stab Knife Model/Catalog Number: QKN1501 Software Version: No software Product Descripti… by Tecfen Medical, citing sterility assurance for Ophthalmic knives.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1949-2025 |
| 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: 15 degree Stab Knife Model/Catalog Number: QKN1501 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Stab knives are used to make precise and fluid tight incisions during eye surgeries such as cataract procedures, vitreoretinal surgery, glaucoma surgery, corneal surgery, and oculoplastic procedures. Component: No
Reason
Sterility assurance for Ophthalmic knives.
Identifiers
| code_info | Lot Code: Manufacture date: 2024-11-25 Expiration date: 2027-11-24 Lot number: ZGY23100713-01 UDI: 00817618021286 |
|---|
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-1949-2025%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.