Tecfen Medical recalls 15 degree stab knives (model QKN1501) due to potential sterility issues affecting eye surgery safety. This recall is for specific production lots manufactured on 2024-11-25.
Sterility assurance for Ophthalmic knives.
Tecfen Medical is recalling 15-degree stab knives (model QKN1501) because they may not be sterile, which could lead to infections during eye surgeries. This is serious because eye surgery requires precise, sterile tools to prevent complications.
These knives are designed for eye surgeries and must be sterile to prevent infections. If not properly sterilized, they could cause serious infections or complications during surgery.
Ophthalmic surgeons and medical facilities using Tecfen Medical's 15-degree stab knives (model QKN1501) manufactured on November 25, 2024, are affected. The highest risk is for procedures requiring sterile instruments.
Check for the model number QKN1501 on the knife packaging. The product was manufactured on November 25, 2024, with lot number ZGY23100713-01.
Immediately stop using the knife if it has the model number QKN1501 and was manufactured on November 25, 2024.
The knives may not be sterile, which could lead to infections during eye surgeries.
Check for model number QKN1501 on the knife packaging.
The product was manufactured on November 25, 2024.
We’ve drafted a message you can send Tecfen Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1949-2025 — Tecfen Medical Tecfen Medical Hello, I own a Tecfen Medical that is covered by recall Z-1949-2025 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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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.
