Medline recalls 67 convenience kits for potential sterility issues due to calibration problems in sterilization equipment. All kits were exposed to validated cycles but may not meet sterility standards. Check product models and lot numbers listed in the recall.
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 67 different convenience kits because calibration issues in the sterilization equipment used to package them could lead to reduced sterility. This means the kits might not be as clean as they should be, which is risky for medical procedures.
The sterilization equipment used to package these kits had calibration issues that could impact the sterility assurance level (SAL). While the kits were exposed to validated sterilization cycles, the calibration problems mean they might not meet the required sterility standards for medical use.
Healthcare professionals and facilities that use these kits for medical procedures are most at risk. The recall affects specific models and lot numbers listed in the notice.
Check the product model number (e.g., ACC010326, CDS981795G) and lot number (e.g., 22HDA973) on the kit packaging. The recall includes 67 specific models and their associated lot numbers.
Look for the model number and lot number on the kit packaging to confirm if it's in the recall list.
If your kit is recalled, contact Medline directly for instructions on how to return or replace it.
The recall indicates potential sterility issues due to calibration problems, so they should not be used until replaced with a recalled model.
Check the model number and lot number on the kit packaging against the list of 67 specific models and lot numbers provided in the recall notice.
Contact Medline directly for instructions on returning or replacing the kit.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1399-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1399-2026 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.
