Recall Z-1949-2025— 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: 15 degree Stab Knife Model/Catalog Number: QKN1501 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. Stab knives are used to make precise and fluid tight incisions during eye surgeries such as cataract procedures, vitreoretinal surgery, glaucoma surgery, corneal surgery, and oculoplastic procedures. 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: 15 degree Stab Knife Model/Catalog Number: QKN1501 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. Stab knives are used to make precise and fluid tight incisions during eye surgeries such as cataract procedures, vitreoretinal surgery, glaucoma surgery, corneal surgery, and oculoplastic procedures. Component: No
Reason for recall
Sterility assurance for Ophthalmic knives.
Data sourced from openFDA. This site is unofficial and independent of the FDA.