Medline recalls 212 convenience kits for labor and delivery use due to calibration issues in sterilization cycles that could affect sterility assurance levels.
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 212 different labor and delivery convenience kits because calibration problems in their sterilization process might compromise the sterility of the products. This means the kits could potentially be contaminated.
The kits were sterilized using equipment that had calibration issues. This could lead to a reduced sterility assurance level, meaning the kits might not be properly sterilized and could be contaminated.
Healthcare providers using these kits for labor and delivery procedures are most at risk. The recall affects kits sold to hospitals and clinics.
Check for model numbers listed in the recall: DYKM2326, DYKMBNDL165, DYKMBNDL31, DYKMBNDL38, DYKMBNDL38B, and others as listed in the full product list. Also look for lot numbers starting with 21, 22, 23, 24, or 25.
Identify your kit's model number and lot number to confirm if it's in the recall list.
Reach out to Medline directly for assistance with the recall process.
The recall states that the kits may have reduced sterility assurance due to calibration issues, so they should not be used until the recall is addressed.
Check the model number and lot number on your kit against the list provided in the recall notice.
Contact Medline to confirm if your kit is recalled and follow their instructions for return or replacement.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2108-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2108-2026 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.
