Medline Industries recalled 150 units of its Convenience Kits on January 7, 2026. Calibration issues with sterilization equipment may affect the sterility assurance level of the products. Patients and healthcare providers must stop using the 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 recalled product is the Medline Convenience Kits, Model Number DYNJ83950. The kits were distributed worldwide, including nationwide in the US. Specific lot numbers affected include 24DBT832, 24CBH626, 23LBR075, 23FBF248, and 23CBG610.
Calibration problems with the sterilization equipment may compromise the sterility assurance level of the recalled products. This issue raises significant health risks for patients relying on these medical devices.
No specific incidents or injuries have been reported related to this recall. The recall was issued proactively due to potential risks.
Patients and healthcare providers should stop using the Medline Convenience Kits immediately. Follow the recall instructions provided by Medline Industries and contact your healthcare provider for guidance.
For more information, contact Medline Industries at 1-800-396-1999 or visit their website. Additional details can be found at the FDA recall notification page.
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