Tecfen Medical: Device Recall

Recall #Z-1954-2025 · 04/25/2025

Class II: Risk

Recall Details

Recall Number
Z-1954-2025
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
42 units

Reason for Recall

Sterility assurance for Ophthalmic knives.

Product Description

Brand Name: Tecfen Medical Product Name: 2.0mm Crescent Knife Angled Bevel Up Model/Catalog Number: QKN1010 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile and packaged individually in Tyhvek 1059B. The crescent knife is used to create smooth, curved incisions for corneal transplant procedures, used in small incision cataract surgery and phacoemulsification to create self-sealing scleral tunnels, used for creating tunnel incisions in the sclera and cornea during procedures like trabeculectomy. 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

View all recalls by Tecfen Medical →

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.