Medline recalls 75 convenience kits with potential sterility issues due to calibration problems during sterilization. Products may not meet sterility standards, but no injuries reported. Check model numbers and lot numbers for affected items.
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 75 different convenience kits that may not be sterile because of calibration issues during the sterilization process. This could lead to infections if the kits are used for medical purposes.
The calibration issues in the sterilization equipment could result in the kits not meeting the required sterility standards. This means the kits might not be sterile when used, increasing the risk of infection during medical procedures.
Healthcare professionals and medical facilities that use these convenience kits for surgical procedures or patient care. The risk is highest for those using the kits in critical medical settings.
Check the model number and lot number on the kit. Affected kits include specific models like CDS820080N, CDS983523G, and others listed in the recall notice. Lot numbers range from 20LDB302 to 25EBK673.
Look for the model number and lot number on the kit to determine if it's affected. Affected models include CDS820080N, CDS983523G, and others listed in the recall.
The recall states that the kits may not meet sterility standards due to calibration issues, 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 CDS820080N, CDS983523G, and others listed in the recall notice.
The recall does not specify a remedy, so contact Medline directly for guidance on how to handle affected kits.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1417-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1417-2026 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.