Medline recalls specific convenience kits for tracheostomy due to potential sterility issues from calibration problems in sterilization packaging. Affected kits may not be sterile, risking infection.
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 that could have been improperly sterilized due to calibration issues in the packaging process. This means the kits might not be sterile, increasing infection risk for medical users.
The calibration issues in the sterilization and packaging cycles could lead to the kits not meeting sterility standards. This means the medical devices might be contaminated, increasing infection risk during procedures.
Healthcare professionals and medical facilities using the recalled Medline Convenience Kits for tracheostomy care are most at risk of potential infection if the kits are not sterile.
Check for model numbers DYKMBNDL55, DYKMBNDL55A, or DYNJ85691 with specific lot numbers listed in the recall notice. The kits were sold with UDI-DI codes and lot numbers from 21ABK325 to 24ABR853.
Identify the model number and lot number on the kit to confirm if it's affected by this recall.
Medline identified calibration issues in the sterilization and packaging cycles that could impact the sterility assurance level of the kits.
The recall indicates potential sterility issues, so affected kits should not be used until the recall is addressed.
Check for model numbers DYKMBNDL55, DYKMBNDL55A, or DYNJ85691 with specific lot numbers listed in the recall notice.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2115-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2115-2026 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.
