Agency classClass IIOur severity:High FDA (Devices)·Z-1951-2025·Announced 2025-06-18

Tecfen Medical 2.4mm Slit Knife Angled Ophthalmic Knife Recall

Tecfen Medical is recalling its 2.4mm Slit Knife, Angled (Model QKN2461) due to sterility assurance concerns. The ophthalmic knife is used to create precise incisions for controlled entry into the eye.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving sterility concerns for a medical device used in eye surgery. Sterility failures in ophthalmic instruments pose a risk of serious infection and harm; no reported illnesses are stated, making this a high-risk product recall without reported adverse events, consistent with a score of 3.

Plain-English summary

Tecfen Medical is recalling 115 units of its 2.4mm Slit Knife, Angled (Model QKN2461), an ophthalmic knife used to create precise incisions for controlled entry into the eye. The recall is due to sterility assurance concerns.

The affected product was manufactured on November 21, 2024, with an expiration date of November 20, 2027. The lot number is ZGY24081907-02. The product was distributed nationwide in Connecticut and Minnesota, as well as internationally to the Dominican Republic, Saudi Arabia, Mexico, Chile, Iran, South Africa, Honduras, United Arab Emirates, Qatar, and Bangladesh, Brazil, and Israel.

Healthcare facilities and individuals who have received this product should discontinue use and contact Tecfen Medical for further instructions regarding the recalled units.

The recalled product

Product: Brand Name: Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Model/Catalog Number: QKN2461 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…
Manufacturer: Tecfen Medical
Category: Medical Device — Ophthalmic Surgical Instrument
Hazard: sterility-failure
infection-risk
Affected units: 115

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 7 recalled by Tecfen Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Same manufacturer · Tecfen Medical

See all →

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Same hazard · sterility failure