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 – Do Not Use Non-piercing Devices to Measure Blood Glucose
FDA Safety Communication On February 21, 2024 the U.S. Food and Drug Administration (FDA) issued a safety communication regarding the use of smartwatches or smart rings that claim to measure blood glucose levels without the need for skin piercing. Its cautionary...
Medos International Recalls CEREBASE DA Guide Sheath
Urgent Class I Recall Notice Medos International Sàrl has issued an urgent recall for the Cerenovus CEREBASE DA Guide Sheath, a neurovascular catheter commonly used in procedures requiring precise navigation and access to blood vessels in the brain. The recall was...
Asensus Surgical Inc Issues Recall for Senhance Surgical System
Class I Recall Notice Asensus Surgical Inc. has announced a recall for its Senhance Surgical System due to malfunctions leading to unintended movement of the robotically-assisted surgical device. Device Use The Senhance Surgical System is a vital tool utilized in...