Tecfen Medical: Device Recall
Recall #Z-1951-2025 · 04/25/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1951-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Tecfen Medical
- Status
- Ongoing
- Date Initiated
- 04/25/2025
- Location
- Santa Barbara, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 115 unit
Reason for Recall
Sterility assurance for Ophthalmic knives.
Product Description
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
Distribution Pattern
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.
Other Recalls by Tecfen Medical
- Class II: Risk 04/25/2025
- Class II: Risk 04/25/2025
- Class II: Risk 04/25/2025
- Class II: Risk 04/25/2025
- Class II: Risk 04/25/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.