Medline Industries recalled 12,418 surgical kits on January 7, 2026, after identifying calibration issues in sterilization equipment. The defects could compromise sterility assurance levels of the devices. Healthcare providers and patients must stop using the affected products 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 multiple models of Medline surgical kits, including ROBOTIC GYN CDS-1 (Model CDS982893I) and GYN LAPAROSCOPY CDS (Model CDS983300J). These kits were widely distributed in the U.S. and internationally.
Calibration issues in sterilization equipment could impact the sterility assurance level (SAL) of the recalled surgical kits. This defect poses a significant risk to patient safety during medical procedures.
No injuries or deaths related to this recall have been reported as of now. However, the potential for compromised sterility raises serious health concerns.
Patients and healthcare providers should stop using the affected kits immediately. Contact Medline Industries for further instructions and follow the recall notifications provided.
For more details, contact Medline Industries at 1-800-633-5463 or visit their website at www.medline.com.
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