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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Medline Convenience Kits are medical kits containing instruments and supplies for surgical procedures. Healthcare providers purchase these kits to ensure they have all necessary tools for specific surgeries.
Calibration issues with the sterilization equipment may compromise the sterility of the kits, increasing the risk of infection during surgical procedures.
This recall is not part of a broader industry pattern.
Patients and healthcare providers face possible infection risks, highlighting the urgency to stop using these kits.
Model numbers and lot numbers can typically be found on the product box or label attached to the kit.
Expect 4-6 weeks for the refund processing after returning the product.
Keep a record of all communications with the manufacturer, including emails and phone call details.
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.
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