Medline recalls 35 convenience kits for potential sterility issues due to calibration problems in sterilization packaging. Affected kits include specific models and lot numbers. Consumers should check their kits and contact Medline for details.
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 35 different surgical convenience kits because calibration issues in their sterilization process might compromise the sterility of the kits. This could lead to infections if the kits are used without proper sterility.
The calibration problems in the sterilization and packaging cycles could potentially affect the sterility assurance level (SAL) of the kits. This means the kits might not be sterile when used, increasing the risk of infection during medical procedures.
Healthcare professionals and surgical staff who use these kits in medical settings. The risk is low for most users since the kits are designed for professional use and the issue is related to sterilization calibration.
Check for model numbers: DYKMBNDL84A, DYKMBNDL87A, DYNDH1143C, DYNDH1873, DYNDH1934, DYNJ17489I, DYNJ48539, DYNJ48539A, DYNJ59897B, DYNJ82998. Also check lot numbers listed in the recall notice.
Look for the model number and lot number on the kit packaging to confirm if it is affected.
Medline has identified calibration issues in the sterilization and packaging cycles that could impact the sterility assurance level of the kits.
Check the model number and lot number on the kit packaging. Affected kits include specific models like DYKMBNDL84A and lot numbers listed in the recall notice.
No, the recall is for potential sterility issues, but healthcare professionals should check their kits and contact Medline if they have the affected models.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1392-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1392-2026 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.