Medline recalls 17 models of Convenience Kits (DYKA1343A) due to potential contamination from sterilization calibration issues. Products may not be sterile, risking infection during medical procedures.
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 17 different models of Convenience Kits (model DYKA1343A) because calibration problems during sterilization could lead to contaminated products. This means the kits might not be sterile, which could cause infections if used in medical procedures.
The sterilization equipment used to package these kits had calibration issues. This means the kits might not be sterile after being processed, potentially leading to infections if used in medical procedures.
Healthcare workers using these kits for medical procedures are most at risk. The kits are sold to hospitals and clinics.
Check for the model number DYKA1343A on the kit. Lot numbers range from 21CBV232 to 25LBC732. These kits were sold starting in 2021.
Look for the model number DYKA1343A on the kit to confirm it's recalled.
Reach out to Medline Industries for specific instructions on how to handle the recalled kits.
The recall indicates potential contamination risks, so they should not be used until Medline provides instructions.
Check for the model number DYKA1343A and lot numbers between 21CBV232 and 25LBC732.
Contact Medline Industries directly for specific instructions on disposal or return.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1410-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1410-2026 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.
