Cardinal Health 200 recalled all lots of its Anti-Reflux Valves on September 18, 2025, after reports of breakage due to excessive force. The recall affects products distributed worldwide, including in the U.S. Consumers must stop using the valves immediately and follow manufacturer guidance.
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 recalled product code is 266197, identified as Salem Sump Anti-Reflux Valve, CE marked. It was distributed worldwide, and the recall affects all lots.
The firm received complaints about breakage of the Anti-Reflux Valve due to excessive force during use. This poses a significant risk to patients and healthcare providers.
The recall does not specify the number of incidents or injuries reported. However, the hazard level is classified as HIGH.
Stop using the device immediately. Follow the recall instructions provided by Cardinal Health or contact your healthcare provider for further instructions.
For more information, contact Cardinal Health 200, LLC or visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0209-2026.
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