Medline Industries, LP recalled over 70 million surgical gowns on January 7, 2026, due to sterilization calibration issues. These issues may compromise the sterility assurance level of the gowns, posing a potential health risk. Healthcare providers and patients should stop using these gowns immediately and follow the recall instructions.
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 70,376,042 surgical gowns, with model numbers such as DYNJP2001, DYNJP2001S, and DYNJP2101. These gowns were distributed worldwide and sold in cases containing various quantities. The gowns have been manufactured and distributed since 2026.
Calibration issues in sterilization equipment may affect the sterility of the gowns. While the products underwent validated sterilization cycles, the identified calibration problems raise concerns about their safety for medical use.
No specific injuries or incidents have been reported related to this recall. The potential health risk stems from compromised sterility of the gowns.
Immediately stop using the recalled surgical gowns. Follow the instructions sent by Medline Industries, LP, and contact your healthcare provider for further guidance.
For more information, contact Medline Industries at 1-800-396-1999 or visit their website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1424-2026.
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