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Closed Suction Catheter Recall: Avanos Medical, Inc. Removes Ballard Closed Suction Systems Due to Risk of Non-Sterility
The FDA is aware that on March 19, 2025, Avanos Medical, Inc. sent all affected customers an Urgent Medical Device Recall Notice due to a failure in the sterilization process for certain lots of Ballard Closed Suction Systems. Use of the affected product may cause serious adverse health consequences, including infection, airway injury, prolonged inflammation, sepsis, or death.
To date, Avanos Medical, Inc. has not reported any serious injuries or deaths associated with this issue.
This recall involves updating instructions for using devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Avanos Medical, Inc. at 1-800-433-2797.
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