Agency classClass IIOur severity:Severe FDA (Devices)·Z-1953-2025·Announced 2025-06-18

Tecfen Medical 20G MVR Sideport Knife ophthalmic sterility recall

Tecfen Medical is recalling its 20G (1.2mm) MVR Sideport Knife Straight (Model QKN2312) ophthalmic knives due to sterility assurance concerns. The recall affects 38 units 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 involving a surgical instrument with a sterility concern. Class II recalls can pose serious risk of adverse health consequences, and sterility failures in ophthalmic surgical instruments present significant infection risk to patients undergoing procedures.

Plain-English summary

Tecfen Medical is recalling its 20G (1.2mm) MVR Sideport Knife Straight, Model QKN2312, an ophthalmic surgical knife used to create precision incisions during vitrectomy procedures. The recall was initiated due to sterility assurance for the affected product.

The recalled lot (ZGY23062808-02) was manufactured on November 21, 2024, with an expiration date of November 20, 2027. A total of 38 units were distributed to healthcare providers in Connecticut and Minnesota in the United States, as well as internationally to the Dominican Republic, Saudi Arabia, Mexico, Chile, Iran, South Africa, Honduras, United Arab Emirates, Qatar, Bangladesh, Brazil, and Israel.

Patients or healthcare providers who have this product should contact Tecfen Medical for further guidance regarding the recall. The affected units are identified by UDI 00817618021422 and lot number ZGY23062808-02.

The recalled product

Product: Brand Name: Tecfen Medical Product Name: 20G (1.2mm) MVR Sideport Knife Straight Model/Catalog Number: QKN2312 Software Version: No software Product Description: This is an ophthalmic knife (manual( that is to be sterile and packaged individually in Tyvek 1059B. MVR sideport…
Manufacturer: Tecfen Medical
Category: Medical Device — Ophthalmic surgical instrument
Hazard: sterility-assurance
infection-risk
Affected units: 38

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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Same hazard · sterility assurance