FDA Medical devices recall ·
Tecfen Medical Product Name: 2.8mm Slit Knife, Angled Model recall
- Recall number
- Z-1952-2025
- 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
- 47 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brand Name: Tecfen Medical Product Name: 2.8mm Slit Knife, Angled Model/Catalog Number: QKN2808 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. Slit knives are used to create precise incisions for controlled entry into the eye. 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: 2024-11-25 Expiration date: 2027-11-24 Lot number: ZGY24041104-01 UDI: 00817618021194
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-1952-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.