Medline Industries recalled 7,725 surgical kits on January 7, 2026, due to potential sterility issues. Calibration problems with sterilization equipment may compromise the sterility assurance level. 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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The recall includes 31 models of Medline Convenience Kits, such as the BAP North Robotic Surgery CDS (Model Number: CDS982407N) and various D&C Packs. These products were distributed worldwide, including the U.S., and were sold under Medline Industries, LP.
Calibration issues with the sterilization equipment may affect the sterility assurance level of the recalled products. This could lead to infections or complications during surgical procedures.
No specific injuries or incidents have been reported related to this recall. The potential risk remains high due to the impact on sterility.
Patients and healthcare providers must stop using the recalled kits immediately. Contact Medline Industries, LP for further instructions or return procedures.
For more information, call Medline Industries at 1-800-396-2006 or visit their website at www.medline.com. Further details are available through the FDA recall notice.
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