Recall Z-1952-2025— Tecfen Medical
Class II · Ongoing
Class II FDA medical device recall by Tecfen Medical, initiated 2025-04-25. FDA's recall record names no specific 510(k) clearance for this event. Product: Brand Name: Tecfen Medical Product Name: 2.8mm Slit Knife, Angled Model/Catalog Number: QKN2808 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. Reason: Sterility assurance for Ophthalmic knives..
- Recalling firm
- Tecfen Medical
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-04-25
- Firm location
- Santa Barbara, CA, United States
Product description
Brand Name: Tecfen Medical Product Name: 2.8mm Slit Knife, Angled Model/Catalog Number: QKN2808 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
Reason for recall
Sterility assurance for Ophthalmic knives.
Data sourced from openFDA. This site is unofficial and independent of the FDA.