Medline Industries recalled 193,157 surgical packs on January 7, 2026, due to sterility assurance issues. The recall affects two model numbers: DYNJP1050UG and DYNJP8401. Healthcare providers and patients must 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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The recall includes two models of surgical packs: Universal Ultraguard Pack (Model Number: DYNJP1050UG) and Shoulder Drape Pouch Pack (Model Number: DYNJP8401). These products were distributed worldwide, including the US, and are packaged in units of 5 and 10 respectively.
Calibration issues with sterilization equipment may compromise the sterility assurance level (SAL) of these surgical packs. This could lead to the use of non-sterile devices in medical procedures, posing significant health risks.
There have been no specific reported incidents or injuries related to this recall. However, the potential for compromised sterility raises serious health concerns.
Stop using the recalled products immediately. Follow the recall instructions provided by Medline. Contact Medline Industries or your healthcare provider for further instructions.
For more information, contact Medline Industries at their official website or customer service number. Alternatively, visit the FDA recall page for ongoing updates.
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