FDA details Class I catheter recall due to safety risk

May 5, 2026 - 01:02

The U.S. Food and Drug Administration has escalated its warning on a specific catheter recall, now classifying it as a Class I event. This is the agency's most serious recall category, indicating a reasonable chance that the product could cause serious injury or death.

The issue first surfaced in April when the FDA issued an initial safety communication. At that time, the agency alerted healthcare providers and patients to potential problems with the device. Now, after further review and reports of adverse events, the FDA has upgraded the recall status. The affected catheters are used in critical medical procedures, and a malfunction could lead to severe complications such as internal bleeding, infection, or device failure during use.

The recall involves specific lots distributed nationwide. The FDA urges healthcare facilities to immediately stop using the affected products and return them to the manufacturer. Patients who have these catheters implanted should not attempt to remove them on their own but should contact their doctor for guidance. The agency continues to monitor the situation and will provide updates as more information becomes available.