Medline recalls 77 convenience kits for potential sterility issues due to calibration problems in sterilization cycles. All kits were exposed to validated cycles but may not meet sterility assurance levels. No remedy specified in recall notice.
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 77 different convenience kits used in medical procedures because calibration issues could affect the sterility of the devices. This means the kits might not be as clean as they should be, which could lead to infections during surgery. The recall does not include a specific fix or return process.
The kits were designed to be sterilized and packaged using validated cycles, but calibration problems could lead to the sterility assurance level (SAL) being compromised. This means the kits might not be sterile enough to prevent infections during medical procedures.
Healthcare professionals and medical facilities that use these kits for procedures like gynecological or robotic surgeries. The risk is low because the issue is about potential sterility, not immediate injury.
Check for the model numbers listed in the recall (e.g., CDS982893I, DYKMBNDL100) and lot numbers (e.g., 24IBO240) on the kits. The kits are used in medical settings for procedures like gynecological surgeries and robotic-assisted surgeries.
Look for the model number and lot number on the kit to see if it matches the recalled items listed in the notice.
No, the recall does not require immediate action. The issue is about potential sterility, not immediate injury, so the risk is low.
Check the model number and lot number on your kit against the list of recalled items provided in the recall notice.
The recall notice does not specify any remedy or action steps for the 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-1415-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1415-2026 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.
