Avanos Recalls Ballard Closed Suction Systems
Due to sterilization failureMay 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.
FDA Issues Warning Letter for Modifications to Infant Products
FDA Issues Warning Letter to Happiest Baby Over SNOO Smart Sleeper Modifications and Quality System Deficiencies The U.S. Food and Drug Administration has issued a Warning Letter to Happiest Baby, Inc., manufacturer of the SNOO Smart Sleeper, citing unapproved device...
FDA Expands Draeger Atlan Anesthesia Workstation Correction
More anesthesia machines added to correction for potential ventilation failure The U.S. Food and Drug Administration (FDA) has designated a recent expansion of Draeger, Inc.'s Atlan anesthesia workstation correction as a Class I recall, the agency's most serious...
Warning Letter to Zoll Medical for Major QMS Violations
Warning Letter to Zoll Medical for Major QMS Violations The U.S. Food and Drug Administration has issued a Warning Letter to ZOLL Medical Corporation citing significant Quality System Regulation (QSR) violations involving corrective and preventive action (CAPA),...