Medline Industries recalled 3,561 convenience kits on January 7, 2026, due to sterilization calibration issues. The recall affects multiple models, including the ENDO KIT W/SYRINGE and ANGIOGRAPHY PACK. Health providers should stop using these kits 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 recalled convenience kits include the following models: DYKE1743, DYNJ0800934D, DYNJ0842873J, DYNJ43415C, DYNJ44066A, DYNJ61978A, DYNJ63542B, DYNJ907452, DYNJC2371G, and PHS853965G. These products were distributed worldwide, including nationwide in the US.
Calibration issues in the sterilization equipment could compromise the sterility assurance level (SAL) of the kits. This may lead to increased risk of infections for patients.
As of now, there are no reported injuries or incidents associated with the recalled kits. The calibration issues were identified during routine checks.
All users should stop using the recalled kits immediately. Contact Medline Industries for return instructions and further information.
For more information, contact Medline Industries at 1-800-396-1999 or visit their website at https://www.medline.com.
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