Medline Industries recalled 117,907 surgical convenience kits on January 7, 2026, due to sterilization calibration issues. The recall affects numerous models, including spinal and knee procedure kits. Patients and healthcare providers should 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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The recall includes models such as CDS940087AG and CDS980832Q, among others. The products were distributed worldwide, including across the US. Prices vary by model.
Calibration issues with sterilization equipment may compromise the sterility assurance level (SAL) of the recalled products. This poses a risk of potential infections during procedures.
No specific incidents or injuries have been reported at this time. The recall is a precautionary measure due to potential sterility concerns.
Stop using the recalled surgical kits immediately. Follow the recall instructions provided by Medline and contact your healthcare provider for further guidance.
For more information, contact Medline Industries at 1-800-396-1999 or visit the recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1421-2026.
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