Medline Industries recalled 4,757 convenience kits on January 7, 2026, due to sterilization calibration issues. The recall affects multiple models, raising concerns about sterility assurance levels. Patients and healthcare providers should stop using these 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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Medline Convenience Kits are pre-packaged medical supplies used in various surgical procedures. These kits are designed for convenience and to ensure that healthcare professionals have essential tools and materials readily available during surgeries.
Calibration issues with the sterilization equipment may compromise the sterility of the kits, increasing the risk of infections for patients. Affected products did undergo validated sterilization cycles, but the potential for contamination remains a serious concern.
This recall is not part of a broader industry pattern.
This recall affects healthcare providers and patients reliant on these kits for surgical procedures, posing a high risk of infection if contaminated kits are used.
Model numbers are typically located on the product packaging or labeling. Check for a barcode or item number.
Expect a timeline of 4-6 weeks for processing refunds or replacements once the product is returned.
Keep copies of any correspondence with Medline, receipts from purchases, and photographs of the recalled product.
The recall includes 57 different models of Medline convenience kits. Affected model numbers include ACC010499 and DYKMBNDL117C. These products were distributed worldwide.
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