Brand Name: Ballard Product Name: Closed Suction Catheters… — Class I medical device recall Z-1524-2025
Ongoing recall by Avanos Medical, Inc., reported 2025-04-23, distributed nationwide. Lack of sterility assurance for closed suction catheter systems
| Recall number | Z-1524-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Avanos Medical, Inc., Alpharetta, GA, United States |
| Recall initiated | 2025-03-19 |
| Classified | 2025-04-16 |
| Reported by FDA | 2025-04-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CA, DE, FR, GB, KR, MX, NZ, SI |
| Quantity | 9,020 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00609038944920, 10609038944927, 20609038944924 |
| Serial numbers | 1555453, 1564227 |
| Model numbers | 220135 |
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
Reason for recall
Lack of sterility assurance for closed suction catheter systems
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1524-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.