Medline recalled 108 units of its Convenience Kits, model DYKMBNDL200A, due to calibration issues affecting sterility. The recall, issued on January 7, 2026, impacts products distributed worldwide. 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 are used in healthcare settings for various medical procedures requiring sterile supplies. They provide necessary items in a single package for convenience and efficiency during procedures.
Calibration issues with sterilization equipment can lead to inadequate sterilization of the kits. This increases the risk of infection and other complications for patients.
This recall is not part of a broader industry pattern.
Consumers must stop using these kits to avoid potential health risks. The recall may cause inconvenience to healthcare providers and patients relying on these supplies.
The model number and lot numbers can typically be found on the product packaging or product insert.
Expect a refund or replacement processing time of 4-6 weeks after following the return instructions provided by Medline.
Keep copies of receipts, correspondence with Medline, and any documentation regarding the recall for your records.
The recalled product is Medline Convenience Kits, model DYKMBNDL200A. The kits were distributed worldwide, including the US, and the recall affects 108 units.
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