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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Medline's convenience kits are designed for use in medical procedures, providing essential tools and sterile equipment for healthcare professionals. They are often used in endoscopic procedures and other medical applications where sterility is crucial.
Calibration issues with the sterilization equipment may affect the sterility of the kits. This defect raises serious concerns about the safety of patients who rely on these medical devices for treatment.
This recall is not part of a broader industry pattern.
The recall affects healthcare providers and patients relying on these kits for safe medical procedures. Compromised sterility may pose immediate health risks, necessitating urgent action from those who possess these products.
Model numbers and lot numbers can typically be found on the product packaging or in the accompanying documentation.
Expect a processing time of 4-6 weeks for refunds or replacements after returning the product.
Keep copies of receipts, correspondence with the company, and any documentation related to the recall for your records.
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.
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