Tecfen Medical: Device Recall

Recall #Z-1949-2025 · 04/25/2025

Class II: Risk

Recall Details

Recall Number
Z-1949-2025
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
1400

Reason for Recall

Sterility assurance for Ophthalmic knives.

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

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.