Ballard Closed Suction Catheters recalled due to sterility assurance failure
Avanos Medical is recalling 1,420 units of Ballard Closed Suction Catheters (Model 2271418-5) due to lack of sterility assurance. The affected product was distributed worldwide, including across the US 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 recall as Class I. Per the rubric, FDA Class I recalls must not score below 4, and when paired with a medical device used in patient care (a closed suction catheter used in respiratory management) the Severe rating is appropriate.
Plain-English summary
Avanos Medical, Inc. is recalling Ballard Closed Suction Catheters, Model 2271418-5 (Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI), due to lack of sterility assurance. A total of 1,420 units have been affected. The lot/serial number is 1555430 (UPC 00609038982632; DSP 10609038982639; Case 20609038982636).
The products were distributed worldwide with US nationwide distribution across 33 states including 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, and Wisconsin. International distribution includes South Korea, New Zealand, Canada, Mexico, Germany, England, Slovenia, France, Austria, and Guadalajara.
Patients or healthcare providers in possession of the recalled product should stop using it and contact Avanos Medical, Inc. for further instructions.
The recalled product
- Product
- Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2271418-5 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
- lack-of-sterility
- 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