Class IIOngoingZ-1955-2025
Tecfen Medical recalls Brand Name: Tecfen Medical Product Name: 3.2mm Slit Knife
Sterility assurance for Ophthalmic knives.
- Ophthalmic Knife
- Under Investigation by firm
Tecfen MedicalCAJun 18, 2025
The FDA has posted 7 enforcement recalls from Tecfen Medical since 2025, none of them Class I (most serious). Most recent report: Jun 18, 2025.
Sterility assurance for Ophthalmic knives.
Sterility assurance for Ophthalmic knives.
Sterility assurance for Ophthalmic knives.
Sterility assurance for Ophthalmic knives.
Sterility assurance for Ophthalmic knives.
Sterility assurance for Ophthalmic knives.
Sterility assurance for Ophthalmic knives.
Firm name as filed with the FDA: “Tecfen Medical”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.