Tecfen Medical recalls 3.2mm Slit Knives (QKN3261) due to potential sterility issues affecting eye surgery safety. Affected units were manufactured November 2024 and expire November 2027.
Sterility assurance for Ophthalmic knives.
Tecfen Medical is recalling its 3.2mm Slit Knives (model QKN3261) because they may not maintain sterility during eye surgery. This could lead to infections if used improperly.
These knives are designed for precise eye surgery incisions but may not stay sterile if the packaging is compromised. The recall addresses potential contamination risks during procedures.
Ophthalmic surgeons and medical facilities using Tecfen Medical's 3.2mm Slit Knives (QKN3261) for eye procedures. The risk is low for most users since these knives are packaged in sterile Tyvek.
Check for the model number QKN3261 on the knife packaging. Units were manufactured on November 21, 2024, and expire November 20, 2027.
Look for the model number QKN3261 on the knife's packaging or label.
The recall indicates potential sterility issues, so it's not recommended for use until the manufacturer confirms safety.
Check for model number QKN3261 on the packaging; units manufactured November 21, 2024, and expire November 20, 2027.
The recall doesn't specify a remedy, so contact Tecfen Medical directly for guidance.
We’ve drafted a message you can send Tecfen Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1955-2025 — Tecfen Medical Tecfen Medical Hello, I own a Tecfen Medical that is covered by recall Z-1955-2025 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.
