Medline Industries recalled 4,853 surgical kits on January 7, 2026 due to potential sterility issues. Calibration problems with sterilization equipment could affect safety. Patients and providers must stop using these 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 recall involves 35 different surgical kits, including models DYKMBNDL104 and DYNJ17219C. These products were distributed worldwide, including across the U.S.
Calibration issues with sterilization equipment may compromise the sterility assurance level of the recalled products. This defect could lead to infections or post-operative complications.
No injuries or deaths have been reported in connection with this recall. The risk of infection from non-sterile products remains a serious concern.
Stop using the recalled surgical kits immediately. Contact Medline Industries or your healthcare provider for further instructions and follow the recall protocol.
For more details, call Medline Industries at 1-800-633-5463 or visit their website at https://www.medline.com.
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