HIGH

Cardinal Health Recalls Anti-Reflux Valves Over Breakage Risk

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.

Quick Facts at a Glance

Recall Date
September 18, 2025
Hazard Level
HIGH
Brand
Cardinal Health 200
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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.

What You Should Do

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

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Product Details

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 Hazard

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.

Reported Incidents

The recall does not specify the number of incidents or injuries reported. However, the hazard level is classified as HIGH.

What to Do

Stop using the device immediately. Follow the recall instructions provided by Cardinal Health or contact your healthcare provider for further instructions.

Contact Information

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.

Key Facts

  • Recall date: September 18, 2025
  • High hazard level due to breakage risk
  • Affected all lots of the Anti-Reflux Valve
  • Worldwide distribution including the U.S.

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Product Code/Product Name/UDI-DI: 266197 Salem Sump" Anti-Reflux Valve CE Marked 10884527022762 8888266197 Salem Sump" Anti-Reflux Valve 10192253012866 All Lots
Affected States
ALL
Report Date
October 29, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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