Medline recalled 553 units of its Convenience Kits on January 7, 2026. Calibration issues with sterilization equipment may compromise product sterility. Healthcare providers and patients must stop using the affected devices 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 recalled models include DYKMBNDL130, DYKMBNDL130A, DYKMBNDL4, LC295, DYKM1977C, and CVI4300. These products were distributed worldwide, including throughout the United States. No price information is available.
Calibration issues with sterilization equipment may impact the sterility assurance level (SAL) of the recalled products. This could lead to infections or other health complications for patients.
No incidents or injuries have been reported in relation to this recall. However, the potential for compromised sterility poses a significant health risk.
Stop using the recalled products immediately. Follow recall instructions provided by Medline and contact your healthcare provider for further guidance.
For more information, contact Medline Industries, LP. Visit their website or the FDA recall page for details.
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