Home / Recalls / Tecfen Medical / Z-1949-2025

Z-1949-2025 Class II Ongoing

Recalled by Tecfen Medical — Santa Barbara, CA

Recall Details

Product Type
Devices
Report Date
June 18, 2025
Initiation Date
April 25, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1400

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.

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.

Code Information

Lot Code: Manufacture date: 2024-11-25 Expiration date: 2027-11-24 Lot number: ZGY23100713-01 UDI: 00817618021286

Other recalls by Tecfen Medical

  • Z-1950-2025 Class II — Brand Name: Tecfen Medical Product Name: 2.2mm Slit Knife, Angled Model/Catalo (April 25, 2025)
  • Z-1955-2025 Class II — Brand Name: Tecfen Medical Product Name: 3.2mm Slit Knife, Angled Model/Catalo (April 25, 2025)
  • Z-1954-2025 Class II — Brand Name: Tecfen Medical Product Name: 2.0mm Crescent Knife Angled Bevel Up (April 25, 2025)
  • Z-1953-2025 Class II — Brand Name: Tecfen Medical Product Name: 20G (1.2mm) MVR Sideport Knife Straigh (April 25, 2025)
  • Z-1952-2025 Class II — Brand Name: Tecfen Medical Product Name: 2.8mm Slit Knife, Angled Model/Catalo (April 25, 2025)
  • Z-1951-2025 Class II — Brand Name: Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Model/Catalo (April 25, 2025)