Tecfen Medical: Medical Device Recall in 2025 - (Recall #: Z-1949-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: April 25, 2025

Date Posted: June 18, 2025

Recall Number: Z-1949-2025

Event ID: 96872

Reason for Recall:

Sterility assurance for Ophthalmic knives.

Status: Ongoing

Product Quantity: 1400

Code Information:

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated