Medline Industries recalled 291 units of burn care kits on January 7, 2026. Calibration issues with sterilization equipment may compromise product sterility. Users should stop using the affected 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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Burn care kits are essential for treating burns and related injuries. Consumers purchase these kits for home use or in healthcare settings for immediate treatment of burn injuries.
The sterilization calibration issues could lead to a lack of sterility in the burn care kits, increasing the risk of infections or complications when used on patients.
This recall is not part of a broader industry pattern.
Consumers who own these burn care kits should stop using them immediately to prevent potential health risks. The recall may cause inconvenience but is critical for patient safety.
Model and lot numbers are usually located on the packaging or the product label of the burn care kit.
Expect a refund or replacement processing time of 4-6 weeks once initiated with Medline Industries.
Keep records of your purchase, any correspondence related to the recall, and photographs of the product for your own records.
The recalled burn care kits include: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BURN CARE PACK-LF, Model Number: DYNJT3437. These products were distributed worldwide and sold in the U.S. since their manufacturing.
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