Tecfen Medical Ophthalmic Knives Recalled for Potential Lack of Sterility

Agency Publication Date: June 11, 2025

Summary

Tecfen Medical is recalling 1,760 ophthalmic knives across seven different models, including stab, slit, sideport, and crescent knives. These manual surgical instruments, used for precise incisions during eye surgeries such as cataract or glaucoma procedures, may not be sterile. The recall affects specific units manufactured in November 2024 and distributed directly to medical facilities.

Risk

A lack of sterility in surgical knives can introduce harmful pathogens directly into the eye during surgery. This poses a serious risk of severe infection, inflammation, or permanent vision loss. No injuries or infections have been reported at this time.

What You Should Do

This recall involves Tecfen Medical ophthalmic knives, including 15-degree Stab Knives, various Slit Knives (2.2mm, 2.4mm, 2.8mm, and 3.2mm), 20G MVR Sideport Knives, and 2.0mm Crescent Knives.
Check the product label for catalog numbers QKN1501, QKN2261, QKN2461, QKN2808, QKN2312, QKN1010, or QKN3261 and the associated lot numbers. See the Affected Products section below for the full list of affected codes.
Stop using the recalled surgical knives immediately.
Contact Tecfen Medical or your distributor to arrange for the return, replacement, or correction of the affected knives.
Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional questions.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: 15 degree Stab Knife

Model / REF:

QKN1501

Lot Numbers:

ZGY23100713-01 (Exp 2027-11-24)

UDI:

00817618021286

Manufacture date: 2024-11-25

Product: 2.2mm Slit Knife, Angled

Model / REF:

QKN2261

Lot Numbers:

ZGY24080201-02 (Exp 2027-11-20)

UDI:

00817618021248

Manufacture date: 2024-11-21

Product: 2.4mm Slit Knife, Angled

Model / REF:

QKN2461

Lot Numbers:

ZGY24081907-02 (Exp 2027-11-20)

UDI:

00817618021156

Manufacture date: 2024-11-21

Product: 2.8mm Slit Knife, Angled

Model / REF:

QKN2808

Lot Numbers:

ZGY24041104-01 (Exp 2027-11-24)

UDI:

00817618021194

Manufacture date: 2024-11-25

Product: 20G (1.2mm) MVR Sideport Knife Straight

Model / REF:

QKN2312

Lot Numbers:

ZGY23062808-02 (Exp 2027-11-20)

UDI:

00817618021422

Manufacture date: 2024-11-21

Product: 2.0mm Crescent Knife Angled Bevel Up

Model / REF:

QKN1010

Lot Numbers:

ZGY24071501-03 (Exp 2027-11-21)

UDI:

00817618021330

Manufacture date: 2024-11-22

Product: 3.2mm Slit Knife, Angled

Model / REF:

QKN3261

Lot Numbers:

ZGY24022804-05 (Exp 2027-11-20)

UDI:

00817618021224

Manufacture date: 2024-11-21

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96872

Status: Active

Manufacturer: Tecfen Medical

Sold By: Medical facilities

Manufactured In: United States

Units Affected: 7 products (1400; 92 units; 115 unit; 47 units; 38 units; 42 units; 26 units)

Distributed To: Connecticut, Minnesota

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall involves Tecfen Medical ophthalmic knives, including 15-degree Stab Knives, various Slit Knives (2.2mm, 2.4mm, 2.8mm, and 3.2mm), 20G MVR Sideport Knives, and 2.0mm Crescent Knives.

Check the product label for catalog numbers QKN1501, QKN2261, QKN2461, QKN2808, QKN2312, QKN1010, or QKN3261 and the associated lot numbers. See the Affected Products section below for the full list of affected codes.

Stop using the recalled surgical knives immediately.

Contact Tecfen Medical or your distributor to arrange for the return, replacement, or correction of the affected knives.

Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional questions.

Affected Products

Product: 15 degree Stab Knife

Model / REF:

QKN1501

Lot Numbers:

ZGY23100713-01 (Exp 2027-11-24)

UDI:

00817618021286

Manufacture date: 2024-11-25

Product: 2.2mm Slit Knife, Angled

Model / REF:

QKN2261

Lot Numbers:

ZGY24080201-02 (Exp 2027-11-20)

UDI:

00817618021248

Manufacture date: 2024-11-21

Product: 2.4mm Slit Knife, Angled

Model / REF:

QKN2461

Lot Numbers:

ZGY24081907-02 (Exp 2027-11-20)

UDI:

00817618021156

Manufacture date: 2024-11-21

Product: 2.8mm Slit Knife, Angled

Model / REF:

QKN2808

Lot Numbers:

ZGY24041104-01 (Exp 2027-11-24)

UDI:

00817618021194

Manufacture date: 2024-11-25

Product: 20G (1.2mm) MVR Sideport Knife Straight

Model / REF:

QKN2312

Lot Numbers:

ZGY23062808-02 (Exp 2027-11-20)

UDI:

00817618021422

Manufacture date: 2024-11-21

Product: 2.0mm Crescent Knife Angled Bevel Up

Model / REF:

QKN1010

Lot Numbers:

ZGY24071501-03 (Exp 2027-11-21)

UDI:

00817618021330

Manufacture date: 2024-11-22

Product: 3.2mm Slit Knife, Angled

Model / REF:

QKN3261

Lot Numbers:

ZGY24022804-05 (Exp 2027-11-20)

UDI:

00817618021224

Manufacture date: 2024-11-21