Medline Industries recalled 10,550 wound care kits on January 5, 2026, due to potential sterility issues. The recall affects several model numbers, including DYKM1361A and DYKM2013. Consumers should stop using the kits immediately and follow the manufacturer's instructions.
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile 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 involves Medline Convenience Kits, including the TRUNK KIT W/EXPIRATION (Model Number: DYKM1361A), TRUNK KIT 1EA (Model Number: DYKM2013), TRUNK KIT 1EA (Model Number: DYKM2013A), RN TRUNK KIT (Model Number: DYKM2699), and TRUNK KIT (Model Number: DYKTRUNK1). These kits were distributed worldwide, including in the U.S., Bahamas, Bermuda, and Cayman Islands.
The manufacturer of the sterile saline wound wash in these kits may not have met the minimum required sterility assurance level. This defect poses a significant risk of infection for patients.
There are no specific reported incidents or injuries associated with this recall at this time. The recall is classified as Class II due to the potential health risk.
Stop using the affected convenience kits immediately. Contact Medline Industries or your healthcare provider for further instructions. Follow the recall instructions provided by the manufacturer.
For more information, contact Medline Industries, LP. Visit their website or refer to the recall notice at the FDA link.
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