Medline Industries, LP recalled 551 units of convenience kits on January 7, 2026. Calibration issues in sterilization equipment may affect product sterility. 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 recall affects two models: ANCILLARY PACK-LF (Model Number: DYNJ0185290G) and OPEN HEART ANESTHESIA ICC-A (Model Number: DYNJ905567A). These products were distributed worldwide, including across the U.S. No specific price was mentioned.
Calibration issues in the sterilization equipment could compromise the sterility assurance level (SAL) of the recalled products. This poses a risk of infection to patients.
There have been no reported incidents, injuries, or deaths associated with this recall. Medline has proactively issued this recall to prevent potential health risks.
Stop using the recalled convenience kits immediately. Follow the recall instructions provided in the notification letter. Contact Medline Industries, LP or your healthcare provider for further instructions.
For more information, consumers can contact Medline Industries, LP directly. Visit the recall page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1384-2026.
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