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Tecfen Medical recalls Brand Name: Tecfen Medical Product Name: 20G (1.2mm) MVR Sideport Knife Straight Model/Catalog Number: QKN2312 Softwa
Recalled June 18, 2025 · FDA recall Z-1953-2025 · Tecfen Medical
Hazard
Sterility assurance for Ophthalmic knives. · FDA Class II
Units
38 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: 20G (1.2mm) MVR Sideport Knife Straight Model/Catalog Number: QKN2312 Software Version: No software Product Description: This is an ophthalmic knife (manual( that is to be sterile and packaged individually in Tyvek 1059B. MVR sideport knives are used to create precision incisions in vitrectomy procedures. Component: No
Manufacturer(s)
Tecfen Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →