Medline Industries recalled 7,494 neuro shunt kits on January 7, 2026, due to sterilization calibration issues. These problems could compromise the sterility assurance level of the products. Patients and healthcare providers should 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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Medline neuro shunt kits are used in surgical procedures to manage cerebrospinal fluid and treat conditions such as hydrocephalus. These kits are essential for neurosurgeons and are typically used in hospitals or surgical centers.
Calibration issues with sterilization equipment may compromise the sterility of the neuro shunt kits. If the kits are not properly sterilized, they may pose a risk of infection to patients upon use.
This recall is not part of a broader industry pattern.
The recall poses a significant health risk as patients using these devices could face severe health complications. Healthcare providers must act quickly to remove these kits from use.
Model numbers are typically located on the product label or packaging.
Expect processing for refunds or returns to take approximately 4-6 weeks.
Keep a record of the recall notice, any correspondence with Medline, and receipts if available.
The recall affects various models of Medline neuro shunt kits, including CDS860018G and CDS860018I. These products were distributed worldwide, including throughout the U.S., and were sold in unspecified quantities. The products were exposed to validated sterilization cycles but failed to meet sterility assurance standards.
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