Medline recalled 108 units of its Convenience Kits, model DYKMBNDL200A, due to calibration issues affecting sterility. The recall, issued on January 7, 2026, impacts products distributed worldwide. Healthcare providers and patients must stop using the kits 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 recalled product is Medline Convenience Kits, model DYKMBNDL200A. The kits were distributed worldwide, including the US, and the recall affects 108 units.
Calibration issues with sterilization equipment may compromise the sterility assurance level (SAL) of the kits. This poses a significant risk of infection or other health complications.
No injuries or incidents have been reported at this time. The potential risk remains high due to the issues with sterility.
Stop using the recalled Convenience Kits immediately. Contact Medline Industries or your healthcare provider for further instructions and follow the recall guidance provided.
For more information, contact Medline Industries, LP. Visit their website or call customer service for assistance.
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