Medline recalls 20 convenience kits due to potential calibration issues during sterilization that could compromise sterility assurance levels. Affected kits include specific models and 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 20 different convenience kits because calibration problems during sterilization might reduce their sterility assurance. This means the kits could be contaminated, posing a risk of infection during medical procedures.
The calibration issues during sterilization and packaging could lead to reduced sterility assurance levels. This means the kits might not be properly sterilized, increasing the risk of contamination during medical procedures.
Healthcare professionals using these kits in medical settings are most at risk. Patients undergoing procedures with contaminated kits could face infection.
Check for model numbers like DYKE1743, DYNJ0800934D, DYNJ0842873J, and others listed in the recall. Look for specific lot numbers such as 23KBQ544, 21EBQ851, etc.
Review the model number and lot number on the kit to confirm if it's affected by this recall.
Medline identified calibration issues during the sterilization and packaging cycles that could impact the sterility assurance level of the kits.
The recall states that the calibration issues may affect sterility assurance, so they should not be used until the recall is addressed.
Check the model number and lot number on the kit. Affected kits include specific models like DYKE1743 with lot numbers such as 23KBQ544 or DYNJ0800934D with lot numbers like 21EBQ851.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1388-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1388-2026 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.
