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U.S. Department of Health and Human Services

Class 2 Device Recall Tecfen Medical

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 Class 2 Device Recall Tecfen Medicalsee related information
Date Initiated by FirmApril 25, 2025
Date PostedJune 11, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1952-2025
Recall Event ID 96872
Product Classification Knife, ophthalmic - Product Code HNN
ProductBrand 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
Code Information Lot Code: Manufacture date: 2024-11-25 Expiration date: 2027-11-24 Lot number: ZGY24041104-01 UDI: 00817618021194
Recalling Firm/
Manufacturer		 Tecfen Medical
6100 Hollister Ave # 3
Santa Barbara CA 93117-3272
For Additional Information ContactKerim Ekonomi
1-805-9671153
Manufacturer Reason
for Recall		Sterility assurance for Ophthalmic knives.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn April 29, 2025, Tecfen Medical initiated a "Urgent Medical Device Recall" Notification to affected consignees via mail and e-mail. Tecfen asked consignees to take the following steps: 1 Please immediately quarantine these Tecfen Medical ophthalmic knife lots. You will receive instructions on how to return them to Tecfen Medical. 2. Please complete the attached medical device recall return response acknowledgement and receipt form by fax to 1-805-967-1295 or email to christina@tecfen.com 3. For any questions, please call 1-805-967-1153, Monday through Friday, 8:00 AM -5:00 PM PST. Alternately, Tecfen can be contacted through email at christina@tecfen.com.
Quantity in Commerce47 units
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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