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
This recall is currently active, issued June 11, 2025. It was issued by Tecfen Medical.
- Company
- Tecfen Medical
- Recall Initiated
- April 25, 2025
- Posted
- June 11, 2025
- Recall Number
- Z-1955-2025
- Quantity
- 26 units
- Firm Location
- Santa Barbara, CA
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Lot Code: Manufacture date: 2024-11-21 Expiration date: 2027-11-20 Lot number: ZGY24022804-05 UDI: 00817618021224
Root Cause
Under Investigation by firm
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.