FDA Medical devices recall ·
Tecfen Medical Product Name: 2.0mm Crescent Knife Angled Bevel Up Model recall
- Recall number
- Z-1954-2025
- Date
- (initiated April 25, 2025)
- Company / brand
- Tecfen Medical
6100 Hollister Ave # 3, Santa Barbara, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 42 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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 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
Why was it recalled?
Sterility assurance for Ophthalmic knives.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: Manufacture date: 2024-11-22 Expiration date: 2027-11-21 Lot number: ZGY24071501-03 UDI: 00817618021330
Distribution
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.
States: Connecticut Minnesota
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1954-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.