FDA Device recall Z-1526-2025
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2271418-5 Software Version: N/A Product Description: Balla…
- FDA Device
- Class I
- ongoing
- Published 2025-04-23
On 2025-04-23 the FDA classified a Class I recall of Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2271418-5 Software Version: N/A Product Description: Balla… by Avanos Medical, citing lack of sterility assurance for closed suction catheter systems.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1526-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-03-19 |
| Published | 2025-04-23 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Avanos Medical |
| Distribution | US |
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
Reason
Lack of sterility assurance for closed suction catheter systems
Identifiers
| code_info | Lot Code: Lot/ Serial Number(s): 1555430 Each: 00609038982632 DSP: 10609038982639 Case: 20609038982636 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1526-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.