Tecfen Medical recalls Brand Name: Tecfen Medical Product Name: 2.8mm Slit Knife

Sterility assurance for Ophthalmic knives.

On April 29, 2025, Tecfen Medical initiated a "Urgent Medical Device Recall" Notification to affected consignees via mail and e-mail. Tecfen asked consignees to take the following steps: 1 Please immediately quarantine these Tecfen Medical ophthalmic knife lots. You will receive instructions on how to return them to Tecfen Medical. 2. Please complete the attached medical device recall return response acknowledgement and receipt form by fax to 1-805-967-1295 or email to christina@tecfen.com 3. For any questions, please call 1-805-967-1153, Monday through Friday, 8:00 AM -5:00 PM PST. Alternately, Tecfen can be contacted through email at christina@tecfen.com.

• FDA enforcement recordOfficial FDA database entry for Z-1952-2025
• FDA device classification · HNNOfficial FDA classification for this device type
• CFR regulation · 21 CFR 886.4350The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Tecfen MedicalSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.