Medline Industries recalled 23,238 convenience kits on January 7, 2026. The recall affects the BAPTIST FLOYD ENDO GI KIT and GI LAB OTHER ENDO KIT due to calibration issues that may compromise sterility. Patients and healthcare providers should stop using the 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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The recall involves the BAPTIST FLOYD ENDO GI KIT (Model Number: DYKE1455B) and GI LAB OTHER ENDO KIT (Model Number: DYKE1721). These products were distributed worldwide, including throughout the U.S. The affected kits were manufactured in various lots.
Calibration issues with the sterilization equipment may affect the sterility assurance level of the recalled products. This situation poses a high risk to patients who rely on these medical devices for safe procedures.
There have been no specific incidents reported, but the potential for compromised sterility raises significant safety concerns. The lack of sterility may lead to severe health risks for patients.
Stop using the affected kits immediately. Contact Medline Industries or your healthcare provider for further instructions on returning the products and obtaining refunds.
For questions, call Medline Industries at 1-800-633-5463 or visit their website for more details on the recall.
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