Medline Industries recalled 59 urology convenience kits on January 7, 2026, due to sterilization calibration issues. These defects may compromise the sterility assurance level of the devices. Patients and healthcare providers should immediately stop using these products and follow recall instructions.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Letter
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The Medline Urology Convenience Kits are designed for use in urological procedures, providing essential tools and equipment for healthcare providers. These kits are often used in clinical settings where sterility is critical for patient safety.
Calibration issues with the sterilization equipment may result in products that are not adequately sterilized, increasing the risk of infection for patients. This could pose serious health risks, especially in urological procedures where sterility is paramount.
This recall is not part of a broader industry pattern.
Consumers using these recalled kits may face serious health risks due to potential infections. The urgency to stop using the devices is critical to ensure patient safety.
Model numbers and lot numbers are typically found on the packaging or labeling of the product.
Expect a refund processing timeline of 4-6 weeks after returning the product.
Keep records of your purchase, including receipts and communication with Medline regarding the recall.
The recall includes the following model numbers: DYKMBNDL106, DYKMBNDL106A, DYKMBNDL188, DYKMBNDL189, DYKMBNDL189A. These kits were distributed worldwide, including the United States, and were sold through multiple retailers.
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