Class II — Tecfen Medical
| Recalling firm | TECFEN MEDICAL |
|---|---|
| Registered facility | TECFEN MEDICAL (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Sterility assurance for Ophthalmic knives. |
| Product | Brand Name: Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Model/Catalog Number: QKN2461 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. Slit knives are used to create precise incisions for controlled entry into the eye. Component: No |
| Quantity | 115 unit |
| Distribution | Worldwide - US Nationwide distribution in the states of Connecticut and Minnesota. The countries of Dominican Republic, Saudi Arabia, Mexico, Chile, Iran, South Africa, Honduras, UAE, Honduras, Qatar, Iran, and Bangladesh, Brazil and Israel. |
| Initiated | 2025-04-25 |
| Classified | 2025-06-11 |
| Recall number | Z-1951-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Tecfen Medical (Z-1951-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96872/
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