CLASS II ONGOING Device recall · Reported 18 Jun 2025 · FDA Enforcement Report

Slit Knife, Angled recalled by Tecfen Medical

Tecfen Medical is recalling Tecfen Medical Slit Knife, Angled, distributed nationwide in the US. The recall was initiated on 25 Apr 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Code: Manufacture date: 2024-11-21 Expiration date: 2027-11-20 Lot number: ZGY24080201-02 UDI: 00817618021248

Quantity recalled92 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1950-2025
FDA event ID: 96872
Recalling firm: Tecfen Medical, Santa Barbara, CA
Classification: Class II
Status: Ongoing
Recall initiated: 25 Apr 2025
FDA classified: 11 Jun 2025
Reported: 18 Jun 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Medical Software

Timeline

25 Apr 2025	Recall initiated by company
11 Jun 2025	Classified by FDA	+47 days
18 Jun 2025	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Sterility assurance for Ophthalmic knives.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Brand Name: Tecfen Medical Product Name: 2.2mm Slit Knife, Angled Model/Catalog Number: QKN2261 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

Where it was distributed

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.

Nationwide Connecticut Minnesota

Questions about this recall

Is Slit Knife, Angled recalled?

Yes. Tecfen Medical recalled Slit Knife, Angled on 25 Apr 2025. The recall is Class II and its status is Ongoing. Recall number Z-1950-2025.

Why was it recalled?

Sterility assurance for Ophthalmic knives.

Which lots are affected?

Lot Code: Manufacture date: 2024-11-21 Expiration date: 2027-11-20 Lot number: ZGY24080201-02 UDI: 00817618021248

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Tecfen Medical

All 7

Reported	Class	Recall	Company	Reason	Where
18 Jun 2025Device	CLASS II	Slit Knife, Angled recalled by Tecfen Medical	Tecfen Medical	Sterility	Nationwide
18 Jun 2025Device	CLASS II	MVR Sideport Knife Straight recalled by Tecfen Medical	Tecfen Medical	Sterility	Nationwide
18 Jun 2025Device	CLASS II	Slit Knife, Angled recalled by Tecfen Medical	Tecfen Medical	Sterility	Nationwide
18 Jun 2025Device	CLASS II	15 degree Stab Knife recalled by Tecfen Medical	Tecfen Medical	Foreign Material	Nationwide
18 Jun 2025Device	CLASS II	Crescent Knife Angled Bevel Up recalled by Tecfen Medical	Tecfen Medical	Sterility	Nationwide

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