Medline recalls convenience kits for tracheostomy care due to potential calibration issues affecting sterility assurance levels. Products include specific model numbers 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 tracheostomy convenience kits because calibration problems during sterilization could compromise the sterility of the products. This means the kits might not be safe for medical use.
The calibration issues in the sterilization process might lead to products not meeting sterility standards. This could result in infections for patients during medical procedures.
Healthcare professionals using Medline tracheostomy convenience kits are most at risk. Patients receiving these kits could be exposed to infection if the products are not sterile.
Check for model numbers DYKMBNDL55, DYKMBNDL55A, or DYNJ85691 on the kits. Products were sold with specific lot numbers listed in the recall notice.
Look for model numbers DYKMBNDL55, DYKMBNDL55A, or DYNJ85691 on the kits.
Medline identified calibration issues in the sterilization process that could impact the sterility assurance level of the kits.
The affected products include Medline tracheostomy convenience kits with model numbers DYKMBNDL55, DYKMBNDL55A, and DYNJ85691, along with specific lot numbers listed in the recall notice.
The recall does not require immediate action, but you should check your products for the model numbers and lot numbers listed 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-1385-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1385-2026 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.
