Brand Name: Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Model/Catalog Number: QKN2461 Software Version: No
Summary
The FDA issued a Class II for Brand Name: Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Model/Catalo by Tecfen Medical. Reason: Sterility assurance for Ophthalmic knives..
Details
Source
Device Recall
External ID
Z-1951-2025
Action Date
2025-06-18
Status
Ongoing
Category
device
Product Description
Brand Name: Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Model/Catalog Number: QKN2461 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
Lot/Code Info: Lot Code: Manufacture date: 2024-11-21 Expiration date: 2027-11-20 Lot number: ZGY24081907-02 UDI: 00817618021156
Quantity Affected: 115 unit
Reason for Recall
Sterility assurance for Ophthalmic knives.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-25
Company
Santa Barbara, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 180 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Tecfen Medical has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Tecfen Medical) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Tecfen Medical have FDA actions?
Tecfen Medical has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1951-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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