FDA Device recall Z-0209-2026
Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Valve CE Marked 8888266197 Salem Sump" Anti-Reflux Valve
- FDA Device
- Class II
- ongoing
- Published 2025-10-29
On 2025-10-29 the FDA classified a Class II recall of Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Valve CE Marked 8888266197 Salem Sump" Anti-Reflux Valve by Cardinal Health 200, citing firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0209-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-18 |
| Published | 2025-10-29 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Cardinal Health 200 |
| Distribution | US |
Product
Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Valve CE Marked 8888266197 Salem Sump" Anti-Reflux Valve
Reason
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
Identifiers
| code_info | Product Code/Product Name/UDI-DI: 266197 Salem Sump" Anti-Reflux Valve CE Marked 10884527022762 8888266197 Salem Sum…Product Code/Product Name/UDI-DI: 266197 Salem Sump" Anti-Reflux Valve CE Marked 10884527022762 8888266197 Salem Sump" Anti-Reflux Valve 10192253012866 All Lots |
|---|
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-0209-2026%22
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