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

Recall Insight

This FDA Devices action (record #Z-1955-2025) was formally reported on June 18, 2025, with the manufacturer initiating the action on April 25, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Tecfen Medical is listed as the recalling firm, operating out of Santa Barbara, CA. Federal records indicate 26 units units are affected.

The documented reason for this recall is: Sterility assurance for Ophthalmic knives. Distribution data in the federal record shows the product reached: 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 Banglad…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 1 year old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.