Medline recalls two convenience kit models due to potential sterility risks from calibration problems during sterilization. Affected products may not meet 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 two specific convenience kits because calibration issues during sterilization could compromise their sterility. This means the kits might not be safe for medical use if they are used without proper sterilization.
The calibration issues in the sterilization equipment could lead to products not meeting sterility standards. This means the kits might not be safe for medical use if they are used without proper sterilization.
Healthcare workers using these kits for medical purposes are most at risk. The recall affects specific models sold with particular lot numbers.
Check for model numbers DYNJ35363A (DRAPE PACK) or SPTPCD10005 (SICK KIDS-GENERAL CUSTOM SPLIT). Products with lot numbers 21BBP020 or 24JBB041 are affected.
Identify the model number and lot number to confirm if your product is affected.
Medline has identified calibration issues that could impact the sterility assurance level of the products during sterilization.
The official recall notice does not specify a remedy, so check the product details to see if it is affected.
The recall is due to potential sterility risks, but the official notice does not indicate a risk of serious injury.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1409-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1409-2026 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.
