FDAClass IIJune 18, 2025

Brand Name: Tecfen Medical Product Name: 2.4mm Slit recall: Sterility Concern

Brand Name: Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Model/Catalog Number: QKN2461 Software Version: No software Product Description…

Why was Brand Name: Tecfen Medical Product Name: 2.4mm Slit recalled?

Sterility assurance for Ophthalmic knives.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Code: Manufacture date: 2024-11-21 Expiration date: 2027-11-20 Lot number: ZGY24081907-02 UDI: 00817618021156

Product
Brand Name: Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Model/Catalog Number: QKN2461 Software Version: No software Product Description…
Recalling firm
Tecfen Medical
Quantity
115 unit
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.
Recall date
June 18, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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