Medline recalls specific urology kits due to potential sterility assurance level issues from calibration problems in sterilization packaging. Affected kits include models DYKMBNDL106, DYKMBNDL106A, DYKMBNDL188, DYKMBNDL189, and DYKMBNDL189A with specific 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 is recalling urology convenience kits that may not be sterile due to calibration issues in the sterilization process. This could lead to infections if the kits are used without proper sterility. Consumers should check the model numbers and lot numbers listed to see if their kit is affected.
The calibration issues in the sterilization equipment could impact the sterility assurance level of the kits. This means the kits might not be sterile when packaged, increasing the risk of infection if used improperly.
Healthcare professionals and medical facilities using the recalled urology convenience kits. Those most at risk are users who might have the kits in their practice without verifying sterility.
Check for model numbers DYKMBNDL106, DYKMBNDL106A, DYKMBNDL188, DYKMBNDL189, or DYKMBNDL189A with specific lot numbers listed in the recall notice. The kits were sold with certain lot numbers between 21BBG085 and 21JLA521.
Look for the model numbers DYKMBNDL106, DYKMBNDL106A, DYKMBNDL188, DYKMBNDL189, or DYKMBNDL189A with lot numbers from 21BBG085 to 21JLA521.
The recall states there is a potential risk to sterility, but the kits are not unsafe to use if they are not affected by the calibration issues. Affected kits may not be sterile.
Check the model number and lot number on your kit. Affected kits have model numbers DYKMBNDL106, DYKMBNDL106A, DYKMBNDL188, DYKMBNDL189, or DYKMBNDL189A with specific lot numbers listed in the recall notice.
The recall does not specify a remedy, so affected kits should be checked for sterility before use. If unsure, contact Medline directly for further guidance.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1416-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1416-2026 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.
