Medline recalls convenience kits with model DYKMBNDL200A due to potential sterility assurance level issues from calibration problems during sterilization. Affected kits include specific lot numbers from 2022-2025.
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 convenience kits with model number DYKMBNDL200A because calibration issues during sterilization could compromise sterility. This means the kits might not be sterile as intended, which is critical for medical use.
The calibration issues in the sterilization equipment might lead to the kits not being sterile enough. This could happen because the equipment used to package the devices wasn't calibrated correctly, potentially allowing contaminants to enter the kits.
Healthcare workers using these kits for medical procedures are most at risk. Patients could be exposed to infections if the kits are not properly sterile.
Check for the model number DYKMBNDL200A on the kit. Affected kits have specific lot numbers listed in the recall: 22KBD675 through 25HBD027.
Look for the model number DYKMBNDL200A on the kit to confirm if it's affected.
Reach out to Medline Industries for specific instructions on how to handle affected kits.
The model number is DYKMBNDL200A.
Affected lot numbers range from 22KBD675 to 25HBD027.
The recall states that the kits may not be sterile due to calibration issues, but there's no specific test mentioned.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2121-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2121-2026 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.
