Medline Industries recalled 9,051 surgical kits on January 7, 2026, due to sterilization calibration issues. The recall affects multiple model numbers and poses a high hazard risk. 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's surgical kits are utilized in various medical procedures, providing essential instruments and materials for healthcare professionals. These kits are critical in ensuring the safety and effectiveness of surgical operations.
Calibration issues in sterilization equipment can lead to insufficient sterilization of the kits, increasing the risk of infection in patients. This is particularly concerning in surgical settings where sterility is paramount.
This recall is not part of a broader industry pattern.
Patients and healthcare providers should act quickly to return these products to avoid potential health risks associated with compromised sterility.
Model and lot numbers can typically be found on the product packaging or label attached to the kit.
Expect processing times for refunds or replacements to take 4-6 weeks after returning the recalled products.
Keep records of your purchase, return communications, and any correspondence with Medline regarding the recall.
The recall includes various surgical kits such as CHP Cochlear Supplement CDS (Models CDS983069G, CDS983069I) and ENT Head and Neck Kits (Models DYKMBNDL156, DYNJ41169). These kits were distributed worldwide, including the U.S., from various healthcare facilities.
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