Tecfen Medical recalls 2.2mm Slit Knives (Model QKN2261) due to potential sterility issues affecting eye surgery safety. This recall covers specific production lots.
Sterility assurance for Ophthalmic knives.
Tecfen Medical is recalling 2.2mm Slit Knives (Model QKN2261) because they may not be sterile as required for eye surgery. Using these knives could risk infection or complications during eye procedures.
These knives are designed to be sterile through gamma radiation and packaged in Tyvek. If not properly sterilized, they could introduce infection during eye surgery. The recall focuses on specific production lots with known manufacturing dates.
Ophthalmic surgeons and medical professionals who use these knives for eye procedures. Patients undergoing eye surgery with this specific knife model are at risk if the knife is not sterile.
Check for the model number QKN2261 on the knife packaging. The knives were manufactured on November 21, 2024, and expire November 20, 2027. Lot numbers start with ZGY24080201-02.
Verify if the knife has a lot number starting with ZGY24080201-02 and was manufactured on November 21, 2024.
The knives may not be sterile as required for eye surgery due to potential issues with the gamma radiation sterilization process.
Look for the model number QKN2261 on the packaging. The knives were manufactured on November 21, 2024, with lot numbers starting with ZGY24080201-02.
The recall does not specify a remedy, so contact Tecfen Medical directly for guidance on handling the item.
We’ve drafted a message you can send Tecfen Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1950-2025 — Tecfen Medical Tecfen Medical Hello, I own a Tecfen Medical that is covered by recall Z-1950-2025 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.
