Medline Industries recalled 2,740 surgical kits on January 7, 2026. Calibration issues with sterilization equipment jeopardize the sterility assurance level of the products. Healthcare providers and patients must stop using these 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 recall affects the following kits: KIT SURG ONC EXCISION BREAST (Model DYKMBNDL84A), KIT SURG ONC EXPLORATORY LAP (Model DYKMBNDL87A), CT BIOPSY TRAY (Model DYNDH1143C), and several others. The products were distributed worldwide and sold in the U.S. since their manufacturing.
Calibration issues with the sterilization equipment may compromise the sterility assurance level of the kits. This raises the risk of infection for patients undergoing procedures using these devices.
No specific incidents or injuries have been reported related to this recall. However, the risk of infection presents a significant concern.
Stop using the recalled surgical kits immediately. Follow the instructions provided by Medline Industries for returning the products.
Contact Medline Industries, LP for further instructions. Visit their website or call customer service for assistance.
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