Tecfen Medical recalls 2.8mm Slit Knives (model QKN2808) 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 2.8mm Slit Knives (model QKN2808) because they may not maintain sterility after gamma radiation processing. This could lead to infections during eye surgery if the knife is not properly sterile.
These knives are meant to be sterile through gamma radiation. If the sterility process failed, they could cause infections during eye surgery. However, the recall indicates a potential issue with the packaging or sterilization process.
Ophthalmic surgeons and medical facilities using Tecfen Medical's 2.8mm Slit Knives (model QKN2808) for eye procedures. The risk is low since the knives are designed for single-use and packaged in sterile conditions.
Check for the model number QKN2808 on the knife packaging. The knives were manufactured on November 25, 2024, and expire November 24, 2027. They are used in eye surgery procedures.
Verify if the knife is packaged in Tyvek 1059B and has the lot number ZGY24041104-01.
The recall is due to potential sterility issues after gamma radiation processing, which could lead to infections during eye surgery.
Look for the model number QKN2808 on the packaging, manufactured on November 25, 2024, with lot number ZGY24041104-01.
The recall record does not mention a specific remedy or fix for the sterility issue.
We’ve drafted a message you can send Tecfen Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1952-2025 — Tecfen Medical Tecfen Medical Hello, I own a Tecfen Medical that is covered by recall Z-1952-2025 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.
