Medline Industries recalled 1,496 convenience kits on January 7, 2026, due to sterilization calibration issues. The recall affects various models, potentially compromising sterility assurance levels. Patients and healthcare providers must stop using these 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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Medline Convenience Kits are designed for surgical procedures and include various tools and devices necessary for operations. Healthcare providers use these kits to ensure sterile conditions during surgeries and procedures.
Calibration issues with sterilization equipment may compromise the sterility of the kits, potentially exposing patients to infection risks. Each kit was exposed to validated sterilization cycles, but the calibration errors raise concerns about their effectiveness.
This recall is not part of a broader industry pattern.
The recall affects healthcare providers who rely on these kits. It may lead to delays in surgical procedures and requires immediate action to ensure patient safety.
Model numbers can be found on the packaging or the product itself, typically near the barcode or on an attached label.
Expect a timeline of approximately 4-6 weeks for processing refunds or replacements after returning the product.
Keep records of your purchase, any correspondence with Medline, and photographs of the product for your records.
The recall includes the following models: DYKM1801B, DYKM1776, DYKM1765A, DYKM1796A, DYKM1756A, among others. The products were distributed worldwide, including the US. No pricing information was provided.
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