Medline recalled 27,320 convenience kits on January 7, 2026, due to calibration issues with sterilization equipment. These defects may compromise the sterility assurance level of the products. Healthcare providers and patients should stop using the affected 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 are used in medical settings for various procedures including obstetrics and gynecology. They typically contain essential tools and supplies needed for safe medical practices.
Calibration issues with sterilization equipment may lead to non-sterile products, increasing the risk of infection or other complications for patients.
This recall is not part of a broader industry pattern.
The recall poses a serious health risk, particularly for patients undergoing medical procedures. Immediate action is required to prevent potential infections.
Model numbers and lot numbers can usually be found on the packaging or the product label.
Expect a refund or replacement processing time of approximately 4 to 6 weeks.
Keep all receipts, correspondence, and any other relevant information regarding your purchase and recall.
The recall includes multiple models of Medline convenience kits, including OB KIT (DYKM2326) and various vaginal delivery packs. These kits were sold worldwide, with distribution across the U.S. since their manufacturing.
Not sure what to do next? Our guide walks you through the process step by step.
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