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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Medline's surgical packs are used in medical procedures to ensure that instruments and surgical fields are sterile. Consumers purchase these packs for their reliability in providing a sterile environment during surgeries.
The calibration issues with sterilization equipment may lead to non-sterile products being used in medical settings, increasing the risk of infection or complications post-surgery.
This recall is not part of a broader industry pattern.
Consumers must stop using the affected surgical packs immediately, which may disrupt medical procedures and require alternatives to be sourced quickly.
Model numbers and lot numbers can typically be found on the packaging or product labels.
Expect a refund or replacement to be processed within 4 to 8 weeks after submission.
Keep copies of any correspondence with Medline and photographs of the product as evidence in case of issues.
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.
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