Z-1949-2025Class II

Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog Number: QKN1501 Software Version...

Name: Z-1949-2025 Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog Number: QKN1501 Software Version...
Creator: Tecfen Medical
Published: 2025-04-25
License: https://open.fda.gov/license/

Tecfen Medical / initiated 2025-04-25 / Open, Classified / root cause: sterility

FDA source

Tecfen Medical began a recall of Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog Number: QKN1501 Software Version: No software Product Description: This is an... on 2025-04-25. FDA classified it as Class II and gives the reason as "Sterility assurance for Ophthalmic knives". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1949-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-25
Posted: 2025-06-11
Recalling firm: Tecfen Medical
Product: Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog Number: QKN1501 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. Stab knives are used to make precise and fluid tight incisions during eye surgeries such as cataract procedures, vitreoretinal surgery, glaucoma surgery, corneal surgery, and oculoplastic procedures. Component: No
Product code: HNN Knife, Ophthalmic
Reason for recall: Sterility assurance for Ophthalmic knives.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: On 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 [email protected] 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 [email protected].
Quantity in commerce: 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.
Product codes and lots: Lot Code: Manufacture date: 2024-11-25 Expiration date: 2027-11-24 Lot number: ZGY23100713-01 UDI: 00817618021286

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1949-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1949-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-11
Z-1950-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-11
Z-1951-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-11
Z-1952-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-11
Z-1953-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-11
Z-1954-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-11
Z-1955-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-11

Product code HNN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)