Tecfen Medical recalls 20G (1.2mm) MVR Sideport Knives (model QKN2312) due to potential sterility issues affecting surgical safety. Affected units were sold from November 2024 to November 2027.
Sterility assurance for Ophthalmic knives.
Tecfen Medical is recalling its 20G (1.2mm) MVR Sideport Knives (model QKN2312) because they may not maintain sterility during use. This could lead to infections during eye surgery if the knife is not properly sterile.
These knives are used in delicate eye surgeries to create precise incisions. If not properly sterile, they could introduce infections during procedures. The recall addresses potential sterility assurance failures in the packaging.
Ophthalmic surgeons and medical professionals who use these knives for eye surgery. The risk is low as the knives are designed to be sterile and packaged individually.
Check for the model number QKN2312 on the knife. The product was sold between November 2024 and November 2027 with lot code ZGY23062808-02.
Ensure the knife is in its original sterile Tyvek packaging before use.
The recall indicates potential sterility issues, but the knives are designed to be sterile and packaged individually. Always check the packaging for integrity.
Look for model number QKN2312 on the knife. The product was sold between November 2024 and November 2027 with lot code ZGY23062808-02.
The recall does not specify a return process, but the manufacturer recommends checking sterility packaging before use.
We’ve drafted a message you can send Tecfen Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1953-2025 — Tecfen Medical Tecfen Medical Hello, I own a Tecfen Medical that is covered by recall Z-1953-2025 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.
