Closed Suction Catheter Recall: Avanos Medical, Inc. Removes Ballard Closed Suction Systems Due to Risk of Non-Sterility

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.  

Affected Product

Product Names:

• Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Y-Adapter
• Ballard Closed Suction System for Neonates/Pediatrics, 10 F, Elbow 
• Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Elbow
• Ballard Closed Suction System for Adults, 14 F, T-Piece 
• Ballard Closed Suction System for Adults, 14 F, DSE
• Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI 
• Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE

Full List of Affected Devices:

What to Do

Do not use the identified affected products listed in the table above.

On March 19, 2025, Avanos Medical, Inc. sent all affected customers an Urgent Medical Device Recall Notice recommending the following actions:

• Check your inventory for the affected products listed above.
• Stop using any affected products immediately and set them aside in a secure location (quarantine them).
• Fill out and email the attached Response Form to productquality@myairlife.com as soon as possible. This helps document what you have and confirms you received this notice.
• If you shared this product with others, please let those customers know about the recall. You can include a copy of this letter when notifying them.
• Return or confirm destruction of the affected products. Once you do, AirLife will send you replacements. For urgent needs, call AirLife at 1-800-433-2797.
• Inform all staff in your organization who need to know about this recall.

Reason for Early Alert

Avanos Medical, Inc. is recalling Ballard Closed Suction Systems due to a failure in the sterilization process. 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.

Device Use

Ballard Closed Suction Systems are used to remove secretions from the airway in patients receiving mechanical ventilation, minimizing the risks associated with disconnecting the ventilator circuit.

Contact Information

Customers in the U.S. with questions about this recall should contact Avanos Medical, Inc. at 1-800-433-2797.

Additional FDA Resources (listed in order of most to least recent):

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.