Avanos Medical recalled its Ballard Closed Suction Systems due to a failure in the sterilization process, which may cause infection, airway injury, prolonged inflammation, sepsis, or death, according to the FDA.


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, according to the FDA.

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.

The FDA reports that 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, the FDA says.

List of Affected Products:

  • 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

See the FDA website for the full list of affected devices.

FDA Recommendations:

Do not use the identified affected products.

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 [email protected] 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.