FDAClass IIJune 18, 2025

Brand Name: Tecfen Medical Product Name: 15 degree Stab recall: Sterility Concern

Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog Number: QKN1501 Software Version: No software Product Description: This is…

Why was Brand Name: Tecfen Medical Product Name: 15 degree Stab 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: 2024-11-25 Expiration date: 2027-11-24 Lot number: ZGY23100713-01 UDI: 00817618021286

Product
Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog Number: QKN1501 Software Version: No software Product Description: This is…
Recalling firm
Tecfen Medical
Quantity
1400
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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