Ballard Closed Suction Catheters recalled due to lack of sterility assurance
Avanos Medical is recalling 9,020 units of Ballard Closed Suction Catheters (Model 220135) due to lack of sterility assurance. The affected devices were distributed worldwide and may pose an infection risk.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I recalls are classified as Critical per the rubric. Lack of sterility assurance in medical devices that enter the airway presents significant risk of serious infection.
Plain-English summary
Avanos Medical, Inc. is recalling 9,020 units of Ballard Closed Suction Catheters, Model 220135 (Ballard Closed Suction System for Adults, 14 F, T-Piece). These single-use medical devices are designed for closed suctioning of airways in adult patients.
The recall is due to a lack of sterility assurance in the affected units. Closed suction catheters must maintain sterile conditions to prevent microbial contamination of the patient's airway, which could cause serious infection.
The affected products have lot numbers 1555453 and 1564227. Distribution was worldwide, including throughout the United States and internationally to Canada, Mexico, Germany, England, France, Austria, Slovenia, South Korea, and New Zealand.
Patients and healthcare providers with questions about this recall or concerns about exposure to affected units should contact Avanos Medical, Inc. or the FDA.
The recalled product
- Product
- Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 220135 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, T-Piece Component: N/A
- Manufacturer
- Avanos Medical, Inc.
- Hazard
- sterility-assurance
- infection-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): 1555453
- 1564227 Each: 00609038944920 DSP: 10609038944927 Case: 20609038944924
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03