Cardinal Health recalled all lots of Salem Sump stomach tubes on September 18, 2025. The recall affects tubes with product codes 264929, 264945, and others due to complaints of valve breakage. Patients and healthcare providers should stop using the devices immediately.
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Cardinal Health 200, LLC or your healthcare provider for instructions. Notification method: Letter
The recall includes multiple models of Salem Sump stomach tubes. Product codes affected are 264929, 264945, 264960, 264986, 5558264957, 5558264965, 5558264973, 5558264981, 8888264911, 8888268060, and 8888268086. These products were distributed worldwide, including all U.S. states.
The firm reported complaints regarding the Anti-Reflux Valve (ARV) breaking under excessive force during use. This failure can lead to significant health risks for patients who rely on these devices.
The recall does not specify the number of reported incidents or injuries, but the hazard level is classified as high due to the potential for serious complications.
Stop using the affected products immediately. Patients should follow the manufacturer’s recall instructions and consult their healthcare provider. Contact Cardinal Health 200, LLC for further guidance.
For more details, visit the recall page at the FDA website or contact Cardinal Health at their customer service number.
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