Ballard Closed Suction Catheters Recalled for Lack of Sterility Assurance
Avanos Medical is recalling Ballard Closed Suction Catheters (Model 20083) due to lack of sterility assurance. The company has distributed approximately 9,960 units worldwide.
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: This is an FDA Class I medical device recall. Class I recalls, per the severity rubric, are assigned a minimum score of 4 (Severe), indicating serious risk of harm to health or safety.
Plain-English summary
Avanos Medical, Inc. is recalling Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Elbow (Model 20083) due to lack of sterility assurance. Approximately 9,960 units have been distributed worldwide, including throughout the United States and internationally to countries including South Korea, New Zealand, Canada, Mexico, Germany, England, Slovenia, France, Austria, and Guadalajara.
The affected lot numbers are 1555215 and 1555217. Affected customers should immediately stop using these devices and contact Avanos Medical, Inc. for instructions on return and replacement. Healthcare providers and patients should report any adverse events to the FDA.
For more information, customers can reference the FDA recall number Z-1523-2025.
The recalled product
- Product
- Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 20083 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Elbow Component: N/A
- Manufacturer
- Avanos Medical, Inc.
- Hazard
- sterility-assurance
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Code: Lot/ Serial Number(s): 1555215
- 1555217 Each: 00609038938311 DSP: 10609038938318 Case: 20609038938315
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