Medline Industries recalled 82,597 surgical kits on January 7, 2026, due to issues with sterilization calibration. The defect may compromise sterility assurance levels of the products. Healthcare providers and patients should 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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Medline surgical kits contain essential instruments and supplies for various surgical procedures. Healthcare providers use these kits to ensure a comprehensive approach to patient care during surgeries.
Calibration issues in sterilization equipment may lead to inadequate sterilization of surgical instruments, potentially allowing microorganisms to survive. This could result in infections for patients undergoing surgery.
This recall is not part of a broader industry pattern.
The recall may cause delays in surgical procedures as healthcare providers must halt the use of affected kits. Patients may need to reschedule surgeries, leading to potential health risks.
Model numbers are typically located on the packaging or instruction manual of the surgical kit.
Expect 4-6 weeks for refund processing after returning the product.
Keep a record of your purchase, any correspondence with the manufacturer, and photos of the kit if applicable.
The recall affects a total of 82,597 units across multiple model numbers, including CDS860015U, CDS860016P, and CDS984244J. These products were distributed worldwide, including throughout the United States. No specific retail price was provided.
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