Brand Name: Tecfen Medical Product Name: 2.8mm Slit Knife, Angled Model/Catalog Number: QKN2808 Software Version: No sof

FDA device recall Z-1952-2025 · posted 2025-06-11 · Open, Classified

Recall details

Recalling firm

Tecfen Medical

Reason for recall

Sterility assurance for Ophthalmic knives.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

HNN

Quantity affected

47 units

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,

Date initiated

2025-04-25

Date posted

2025-06-11

Location

Santa Barbara, CA