Medline Industries recalled 808 lithotomy packs on January 7, 2026, due to calibration issues in sterilization equipment. These problems may compromise the sterility assurance level of the products. Healthcare providers and patients must 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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Lithotomy packs are used in medical procedures to support patient positioning and access. They are essential for gynecological surgeries and related healthcare settings.
The calibration issues in sterilization equipment raise the risk that these packs may not be sterile, potentially leading to infections during medical procedures.
This recall is not part of a broader industry pattern.
Patients and healthcare providers must stop using these lithotomy packs, which may cause disruptions in scheduled procedures and potential health risks.
Model numbers and lot numbers are typically found on the packaging of the lithotomy packs or in accompanying documentation.
Expect a refund processing timeline of 4-6 weeks after submission of your request.
Keep copies of any receipts, correspondence related to the recall, and documentation of your request for a refund.
The recall includes two models of lithotomy packs: Model Number DYNJ83185 and DYNJ83185A. The affected products were distributed worldwide, including in the U.S. The kits were sold at an approximate price of $100.
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