Medline Industries recalled 1,496 convenience kits on January 7, 2026, due to sterilization calibration issues. The recall affects various models, potentially compromising sterility assurance levels. Patients and healthcare providers must stop using these devices immediately.
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 recall includes the following models: DYKM1801B, DYKM1776, DYKM1765A, DYKM1796A, DYKM1756A, among others. The products were distributed worldwide, including the US. No pricing information was provided.
Calibration issues with sterilization equipment may impact the sterility assurance level (SAL) of the recalled products. These issues could potentially lead to infection or other complications for patients.
There are no reported incidents of injury or death associated with this recall at this time. The recall was initiated as a precaution to prevent potential risks.
Stop using the recalled convenience kits immediately. Contact Medline Industries or your healthcare provider for further instructions on returning the products.
For more information, contact Medline Industries, LP. Visit the FDA recall page for detailed instructions.
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