Medline Industries recalled 4,415 surgical kits on January 7, 2026, due to sterilization calibration issues. These issues could compromise the sterility assurance level of the products. Healthcare providers and patients must stop using the 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 Convenience Kits include a range of surgical instruments and supplies used in various medical procedures, particularly gynecological surgeries. These kits are essential for healthcare providers to ensure safe and sterile environments during operations.
Calibration issues with the sterilization equipment may compromise the sterility assurance level of the kits, increasing the risk of infection during surgical procedures.
This recall is not part of a broader industry pattern.
The potential for compromised sterility could lead to serious health risks for patients undergoing surgical procedures, necessitating immediate action from healthcare providers.
Model numbers are typically located on the outer packaging or the instruction manual included with the kit.
Expect a refund or replacement processing time of approximately 4-6 weeks.
Keep records of your purchase, communication with Medline, and any correspondence regarding the recall.
The recall affects various Medline surgical kits including HYSTEROSCOPY, KIT GYN ONCOLOGY LAP, and several VAGINAL HYSTERECTOMY PACK models. The model numbers include CDS984086I, DYKMBNDL91A, DYNJ0373807J, and others. The kits were distributed worldwide, including the US, and all were sold before January 2026.
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