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Tecfen Medical recalls Brand Name: Tecfen Medical Product Name: 3.2mm Slit Knife, Angled Model/Catalog Number: QKN3261 Software Version: No
Recalled June 18, 2025 · FDA recall Z-1955-2025 · Tecfen Medical
Hazard
Sterility assurance for Ophthalmic knives. · FDA Class II
Units
26 units
Sold at
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.
Description
Sterility assurance for Ophthalmic knives.
Product
Brand Name: Tecfen Medical Product Name: 3.2mm Slit Knife, Angled Model/Catalog Number: QKN3261 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile and packaged individually in Tyvek 1059B. Slit knives are used to create precise incisions for controlled entry into the eye. Component: No
Manufacturer(s)
Tecfen Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →