Medline recalls 50+ convenience kits for potential sterility assurance level issues due to calibration problems in sterilization packaging cycles. Products may not meet required sterility standards.
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 50+ convenience kits that were sterilized using equipment with calibration issues. This could mean the kits don't meet the required sterility standards. If you have any of these kits, you should check if they're affected and contact Medline for details.
The sterilization and packaging cycles used for these kits had calibration issues that could potentially impact the sterility assurance level (SAL). This means the kits might not meet the required sterility standards, though the risk to users is low as the issue occurs during manufacturing.
Healthcare facilities and medical professionals who use these kits for procedures. The risk is low as the issue relates to sterility assurance during manufacturing, not direct harm to users.
Check for model numbers listed in the recall (e.g., 00-401824AB, CDS985094F) and lot numbers (e.g., 24IBQ637) on the product packaging. The kits were sold with specific model and lot numbers listed in the recall notice.
Look for model numbers and lot numbers on the product packaging to see if they match the recalled items listed in the notice.
Reach out to Medline Industries for specific guidance on whether your product is affected and for instructions on next steps.
The recall is for potential sterility assurance issues during manufacturing, not direct safety risks. The kits may not meet required sterility standards, but the risk to users is low.
Check the model number and lot number on the product packaging against the list of recalled items provided in the recall notice.
Contact Medline Industries directly for specific guidance on whether your product is affected and for instructions on next steps.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2092-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2092-2026 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.
