Medline recalls PPE kits with model DYK1011945P due to potential calibration issues in sterilization equipment that could impact sterility assurance levels. Affected units include specific lot numbers from 2021-2023.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline is recalling PPE kits with model number DYK1011945P because calibration problems in their sterilization equipment might reduce the sterility of the kits. This could lead to infection risks if the kits are used in medical settings.
The sterilization equipment used to package these kits had calibration issues, which could lower the sterility assurance level. This means the kits might not be properly sterilized, increasing the risk of infection if used in medical procedures.
Healthcare workers and medical facilities that use these PPE kits are most at risk. The recall affects specific lot numbers produced between 2021 and 2023.
Check for the model number DYK1011945P on the kit. Affected units include specific lot numbers from 2021 to 2023 (e.g., 23AFA049, 22LFA068, etc.).
Look for the lot number on the kit, which is listed in the recall notice for specific years (2021-2023).
Medline identified calibration issues in the sterilization equipment that could impact the sterility assurance level of the kits.
The model number is DYK1011945P.
Check the lot number on the kit; affected units include specific numbers from 2021 to 2023 (e.g., 23AFA049, 22LFA068).
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1408-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1408-2026 from Medline. 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.
