FDA recall Z-1950-2025

Tecfen Medical · Class II · device

Product

Brand Name: Tecfen Medical Product Name: 2.2mm Slit Knife, Angled Model/Catalog Number: QKN2261 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

Reason for recall

Sterility assurance for Ophthalmic knives.

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.

Key facts

Status
Ongoing
Initiation date
2025-04-25
Report date
2025-06-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Santa Barbara, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1950-2025