Source: US Department of Health and Human Services – 3
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:
Product Description
REF Number
Lot Number
UDI Information
Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Y-Adapter (Each)
198
1561168
00609038938264
Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Y-Adapter (DSP)
198
1561168
10609038938261
Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Y-Adapter (Case)
198
1561168
20609038938268
Ballard Closed Suction System for Neonates/Pediatrics, 10 F, Elbow
210
1561165
00609038938349
Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Elbow
20083
15552151555217
00609038938311
Ballard Closed Suction System for Adults, 14 F, T-Piece
220135
15554531564227
00609038944920
Ballard Closed Suction System for Adults, 14 F, DSE
2210-5
1555424
00609038983103
Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI
2271418-5
1555430
00609038982632
Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE
227-5
1555468
00609038989655
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.
Content current as of:
07/10/2025
Regulated Product(s)