Medline Industries recalled 4,757 convenience kits on January 7, 2026, due to sterilization calibration issues. The recall affects multiple models, raising concerns about sterility assurance levels. Patients and healthcare providers should stop using these products 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 57 different models of Medline convenience kits. Affected model numbers include ACC010499 and DYKMBNDL117C. These products were distributed worldwide.
Calibration issues with sterilization equipment may compromise the sterility of these medical kits. Medline confirmed that all products underwent validated sterilization cycles but the calibration issues pose a high risk of contamination.
As of the report date, no injuries or illnesses have been specifically linked to the recalled kits. The potential for contamination raises serious health concerns.
Stop using the recalled convenience kits immediately. Contact Medline Industries or your healthcare provider for further instructions. Follow the recall notification provided via letter.
For more information, contact Medline Industries at 1-800-633-5463 or visit their website at www.medline.com.
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