Medline recalls 14 lots of Convenience Kits (Model DYKMBNDL200A) due to potential sterility issues from calibration problems in sterilization equipment. Affected users should check their product labels for lot numbers.
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 14 different lots of Convenience Kits (Model DYKMBNDL200A) because calibration problems in the sterilization equipment might compromise the sterility of the products. This could lead to infections if the kits are used in medical settings.
The sterilization equipment used to package these kits had calibration issues that could reduce the sterility assurance level. This means the kits might not be properly sterilized, increasing infection risk during medical procedures.
Healthcare professionals and medical facilities that use these kits for sterilization are most at risk. The recall affects specific lots produced between 2022 and 2023.
Check the product label for Model Number DYKMBNDL200A and Lot Numbers listed in the recall (22KBD675 to 25CBB549). The kits were sold between 2022 and 2023.
Look for Model Number DYKMBNDL200A and Lot Numbers from 22KBD675 to 25CBB549 on the kit packaging.
Medline identified calibration issues in the sterilization equipment that could impact the sterility assurance level of the kits, potentially leading to infections.
Check the product label for Model Number DYKMBNDL200A and Lot Numbers from 22KBD675 to 25CBB549.
The recall does not require immediate action, but you should check your kits against the listed lot numbers to ensure safety.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1405-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1405-2026 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.
