Ballard Closed Suction Catheters recalled for sterility assurance defect
Avanos Medical is recalling Ballard Closed Suction Catheters (Model 22714183-5) due to lack of sterility assurance. The affected lot was distributed nationwide and internationally.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class I recall. Per the severity rubric, FDA Class I recalls that are not otherwise classified as Critical must be scored at 4 (Severe) or higher. Lack of sterility assurance on a medical device used for respiratory care poses risk of serious infection and qualifies as a Class I defect.
Plain-English summary
Avanos Medical, Inc. is recalling Ballard Closed Suction Catheters, Model 22714183-5 (Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI), Lot/Serial Number 1555426. The recall is due to lack of sterility assurance for the closed suction catheter systems.
The affected lot was distributed nationwide to the states of AL, AZ, CA, CO, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI, as well as internationally to South Korea, New Zealand, Canada, Mexico, Germany, England, Slovenia, France, Austria, and Guadalajara.
Patients using the affected product should contact their healthcare provider. Healthcare facilities should quarantine and not use the affected lot and contact Avanos Medical, Inc. for instructions on product return and replacement.
The recalled product
- Product
- Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI Component: N/A
- Manufacturer
- Avanos Medical, Inc.
- Hazard
- sterility-assurance
- infection-risk
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighMedtronic DLP One-Piece Pediatric Arterial Cannula Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Smart Assist Set Heart Pump Introducer Sheath Leakage
FDA (Devices) · 2026-07-22