Ballard Closed Suction Catheters recalled for lack of sterility assurance
Avanos Medical is recalling Ballard Closed Suction Catheters (Model 2210-5) because they lack adequate sterility assurance. The recall affects approximately 2,080 units distributed worldwide, including across most US states and several countries.
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 recall as Class I, which by the rubric criterion requires a minimum score of 4. Lack of sterility assurance in medical devices used in direct patient contact (closed suction catheters) presents significant risk of serious health consequences including infection.
Plain-English summary
Avanos Medical, Inc. is recalling the Ballard Closed Suction System for Adults (Model 2210-5, 14 F, DSE) because of lack of sterility assurance for the closed suction catheter systems. The affected lot includes approximately 2,080 units with lot/serial number 1555424.
The products were distributed nationwide across the United States, including to the states of Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and internationally to South Korea, New Zealand, Canada, Mexico, Germany, England, Slovenia, France, Austria, and Guadalajara.
Healthcare providers and facilities that received these products should immediately verify that they are not using the affected lot. Any catheters matching lot number 1555424 should be removed from service. Healthcare providers should contact Avanos Medical, Inc. for guidance on product return or replacement procedures.
The recalled product
- Product
- Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2210-5 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, DSE Component: N/A
- Manufacturer
- Avanos Medical, Inc.
- Hazard
- sterility-assurance
- contamination-risk
- 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