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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Medline surgical gowns are used in medical settings to provide protective barriers for healthcare providers and patients during procedures. These gowns are essential for maintaining a sterile environment in operating rooms and other clinical settings.
Calibration issues in the sterilization equipment may lead to gowns that are not properly sterile. This lack of sterility can pose serious risks during surgeries and other medical procedures where infection control is critical.
This recall is not part of a broader industry pattern.
The recall affects a significant number of surgical gowns, which may lead to shortages in medical facilities. Healthcare providers must seek alternatives to maintain safety during procedures.
Model numbers are typically printed on the packaging or labels inside the gowns.
Expect a processing timeline of 4-6 weeks for refunds or replacements after submission of the return request.
Keep records of your purchase, including receipts and any correspondence with Medline regarding the recall.
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.
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