Medline recalls DRAPE PACK-CHOICE convenience kits (model DYNJ63118A) due to potential sterility risks from calibration problems during sterilization. Affected kits were sold with specific lot numbers and UDI-DI codes.
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 DRAPE PACK-CHOICE convenience kits (model DYNJ63118A) because calibration issues during sterilization could compromise the sterility of the products. This means the kits might not be sterile as intended, which is critical for medical use.
The calibration issues in the sterilization equipment could lead to the kits not being properly sterilized. This means the products might not be sterile when used, which is critical for medical procedures.
Healthcare workers using these kits for medical procedures are most at risk. The kits were sold to hospitals and clinics with specific lot numbers and UDI-DI codes.
Check for the model number DYNJ63118A on the kit. Affected kits have UDI-DI codes 10195327644291 and 10195327644292, and lot number 25ABV005.
Look for the model number DYNJ63118A and UDI-DI codes 10195327644291 or 10195327644292 with lot number 25ABV005.
Medline identified calibration issues in the sterilization equipment that could impact the sterility assurance level of the kits.
Check for model number DYNJ63118A, UDI-DI codes 10195327644291 or 10195327644292, and lot number 25ABV005.
The recall record does not specify a remedy, so contact Medline directly for guidance.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1406-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1406-2026 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.
