Agency classClass IIOur severity:Severe FDA (Devices)·Z-1952-2025·Announced 2025-06-18

Tecfen Medical 2.8mm Slit Knife Angled Sterility Assurance Recall

Tecfen Medical is recalling 2.8mm Slit Knife, Angled (Model QKN2808) ophthalmic surgical instruments due to sterility assurance concerns. Affected units were distributed in the US and internationally.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II medical device recall. Although no illnesses or injuries are reported in the source text, the recall involves a sterile surgical instrument with potential for direct patient contact and infection risk if sterility is compromised, meeting the threshold for Severe classification under the rubric criterion for FDA Class II with significant risk implications.

Plain-English summary

Tecfen Medical is recalling the 2.8mm Slit Knife, Angled (Model QKN2808), a manual ophthalmic surgical knife used to create precise incisions for controlled entry into the eye. The recall was initiated due to sterility assurance concerns.

Approximately 47 units were affected. The recalled lot (Lot Number ZGY24041104-01, UDI 00817618021194) was manufactured on 2024-11-25 with an expiration date of 2027-11-24. These units were packaged individually in Tyvek 1059B and sterilized by gamma radiation.

Distribution included US states of Connecticut and Minnesota, as well as the Dominican Republic, Saudi Arabia, Mexico, Chile, Iran, South Africa, Honduras, United Arab Emirates, Qatar, Bangladesh, Brazil, and Israel.

Healthcare providers and consumers in possession of affected units should discontinue use and contact Tecfen Medical for instructions regarding return or replacement of the product.

The recalled product

Product: Brand 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…
Manufacturer: Tecfen Medical
Category: Medical Device — Ophthalmic Surgical Instrument
Hazard: sterility-assurance
infection-risk
Affected units: 47

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

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