Tecfen Medical 2.4mm Slit Knife Recall: Sterility Risk for Eye Surgery

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Contact the company & request your remedy

Recalling firmTecfen Medical6100 Hollister Ave # 3 · Santa Barbara, CA 93117-3272

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Tecfen Medical is recalling its 2.4mm Slit Knife (Model QKN2461) because it may not maintain sterility during eye surgery. This could lead to infections or complications if used without proper sterilization.

Why it’s dangerous

This knife is designed for precise eye incisions but requires gamma radiation sterilization. If not properly sterilized, it could introduce infections during surgery due to contamination.

Who’s affected

Ophthalmic surgeons and medical facilities using this knife for eye procedures. Those with the specific model number QKN2461 are most at risk.

How to tell if you have this one

Check for the model number QKN2461 on the knife's packaging. Units were manufactured on November 21, 2024, and expire November 20, 2027.

Brand
Tecfen Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Sterility Status
Verify if the knife has been properly sterilized using gamma radiation before use.
Contact Manufacturer
Reach out to Tecfen Medical for guidance on sterility verification and potential alternatives.

✎ GovInfoNow

Questions people ask

Is this knife safe for eye surgery?

The recall indicates potential sterility issues, so it may not be safe without proper sterilization. Always confirm sterility with the manufacturer.

When was this knife manufactured?

This knife was manufactured on November 21, 2024.

How long is this knife valid?

The knife expires November 20, 2027.

Take action

Contact Tecfen Medical

We’ve drafted a message you can send Tecfen Medical to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1951-2025 — Tecfen Medical Tecfen Medical

Hello,

I own a Tecfen Medical that is covered by recall Z-1951-2025 from Tecfen Medical.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1951-2025 (April 25, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1951-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Tecfen Medical recalls Brand Name: Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Model/Catalog Number: QKN2461 Software Version: No

Use caution until it’s fixed