Avanos Recalls Ballard Closed Suction Systems

Due to sterilization failure

May result in non-sterile devices

Avanos Medical, Inc. is recalling its Ballard Closed Suction Systems after identifying a failure in the sterilization process, which may result in non-sterile devices. Use of these products could lead to serious health risks, including infection, airway injury, inflammation, sepsis, or death.

No injuries or deaths have been reported to date.

About the Device

The Ballard Closed Suction System is used for removing airway secretions in ventilated patients, helping to maintain ventilation without disconnecting the circuit — a critical function in respiratory care.

Recommended Actions (as of March 19, 2025)

  • Immediately stop using any affected products and quarantine them.
  • Check your inventory for affected items listed in the recall notice.
  • Notify any customers or departments you may have shared the product with.
  • Complete and return the Response Form to: productquality@myairlife.com.
  • Arrange for return or confirm destruction of affected units to receive replacements.
  • Communicate the recall to all relevant staff within your organization.
  • For urgent replacement needs, contact AirLife at 1-800-433-2797.

Need Help?

For questions or support related to the recall, contact Avanos Medical, Inc. at 1-800-433-2797.

Healthcare providers are urged to act promptly to prevent potential harm to patients relying on these critical airway management systems.

Affected Products

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

Click here to see a full list of affected devices.

News

FDA Enforcement

Safety Alerts

Medical Devices

Pharma

New Drugs

Drug Shortages

Class I Correction for Homecare Bed Fire and Entrapment Risks

Medline Homecare Beds: FDA Class I Correction for Fire and Entrapment Risks Medline Industries has issued a critical safety correction involving multiple models of homecare beds following reports of overheating components, electrical hazards, and patient entrapment...

When a Small Process Failure Becomes a Patient Safety Event

What the Erbe Cryoprobe Alert Teaches Us About Modern Device Quality The FDA’s recent Early Alert regarding flexible cryoprobes manufactured by Erbe USA is a textbook example of a fundamental truth in medical device quality. That small manufacturing deviations can...

FDA Flags High-Risk Issue with Erbe Flexible Cryoprobes

FDA Flags High-Risk Issue with Erbe Flexible Cryoprobes The FDA’s Center for Devices and Radiological Health (CDRH) has issued an Early Alert regarding a potentially high-risk issue involving certain flexible cryoprobes manufactured by Erbe USA. Issue Overview Erbe...