Recall Z-1951-2025 ยท HNN Knife, Ophthalmic
Tecfen Medical
Brand Name: Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Model/Catalog Number: QKN2461 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
| Date | Jun 11, 2025 (initiated Apr 25, 2025) |
| Status | Open, Classified |
| Reason | Sterility assurance for Ophthalmic knives. |
| Root cause | Under Investigation by firm |
| Action | 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. Alter |
| Quantity | 115 unit |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.