Tecfen Medical Ophthalmic Knives Recalled for Sterility Assurance
Tecfen Medical is recalling 2.0mm Crescent Knife surgical instruments (Model QKN1010, Lot ZGY24071501-03) due to sterility assurance concerns. The affected devices were distributed worldwide to medical facilities.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—sterility assurance failure in a surgical device could pose infection risk, but no adverse events have been documented. Per the rubric, risk-of-harm products without reported injury score no higher than 3.
Plain-English summary
Tecfen Medical is recalling 2.0mm Crescent Knife Angled Bevel Up surgical instruments (Model QKN1010, Lot ZGY24071501-03) due to sterility assurance concerns. These ophthalmic surgical knives are used to create precise incisions in corneal and scleral tissue during eye surgeries including corneal transplants, cataract surgery, and trabeculectomy procedures.
A total of 42 units of Lot ZGY24071501-03 (manufactured November 22, 2024, expiration November 21, 2027) were distributed to medical facilities in Connecticut and Minnesota in the United States. Additional distribution included the Dominican Republic, Saudi Arabia, Mexico, Chile, Iran, South Africa, Honduras, United Arab Emirates, Qatar, Bangladesh, Brazil, and Israel.
The recalled product
- Product
- 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 kn
- Manufacturer
- Tecfen Medical
- Hazard
- sterilization-failure
Distribution
Distributed nationwide across the United States.
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