Medline recalls PPE kits with model DYK1011945P due to calibration issues that may affect sterility. Check lot numbers 21BFA109 to 25IFA006 for affected items.
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 during sterilization could compromise their sterility. This means the kits might not be safe for medical use if they are used without proper sterilization.
The sterilization equipment used to package these kits had calibration issues, which could lead to reduced sterility assurance. This means the kits might not be properly sterilized, increasing the risk of infection during medical procedures.
Healthcare workers and medical facilities that use these PPE kits for sterilization. The risk is low because the issue is related to calibration during manufacturing, not direct harm from use.
Check for model number DYK1011945P and lot numbers from 21BFA109 to 25IFA006. The kits are sold by Medline Industries, LP.
Look for model number DYK1011945P and lot numbers 21BFA109 through 25IFA006 on the kit packaging.
Medline identified calibration issues in the sterilization equipment used to package these kits, which could impact the sterility assurance level.
No, the recall is for potential sterility issues during manufacturing, not immediate safety risks. You can continue using them if they are not in the affected lot numbers.
Check the model number (DYK1011945P) and lot number on the packaging. Affected lots range from 21BFA109 to 25IFA006.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2104-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2104-2026 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.
