Medline Industries LP recalls 170 convenience kits for potential sterility assurance level issues due to calibration problems in sterilization packaging cycles. Affected kits include various surgical and catheter-related products with specific model numbers and lot numbers.
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 Industries has recalled 170 different convenience kits used in medical settings due to calibration issues in sterilization and packaging cycles. These issues could potentially impact the sterility assurance level of the products, meaning they might not be sterile as intended.
The calibration issues in the sterilization and packaging cycles could lead to a potential decrease in the sterility assurance level of the kits. This means the products might not be sterile as required, which could pose a risk during medical procedures.
Healthcare professionals and medical facilities that use these convenience kits for procedures like catheterization or surgery are most at risk. The recall affects products sold with specific model numbers and lot numbers listed in the notice.
Check for model numbers and lot numbers listed in the recall notice. The affected kits include specific surgical and catheter-related products with model numbers like CDS985094F, DYKMBNDL153, and others, along with corresponding lot numbers.
Identify the model number and lot number of your convenience kit to confirm if it's affected by this recall.
Medline Industries LP recalls 170 convenience kits for potential sterility assurance level issues due to calibration problems in sterilization packaging cycles.
Check the model number and lot number on your kit against the list of affected products provided in the recall notice.
The recall does not specify a remedy, so no action is required beyond checking if your kit is affected.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1389-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1389-2026 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.
