FDA Device recall Z-0407-2018
PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S
- FDA Device
- Class II
- terminated
- Published 2018-01-31
On 2018-01-31 the FDA classified a Class II recall of PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S by Inovo, citing post-market surveillance for Pure Stationary Oxygen Concentrators model CHSOOO and CHSOOOS demonstrate an aggregate complaint/service rate greater than 35% for low oxygen purity (….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0407-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-10-09 |
| Published | 2018-01-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Inovo |
| Distribution | n/a |
Product
PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S
Reason
Post-market surveillance for Pure Stationary Oxygen Concentrators model CHSOOO and CHSOOOS demonstrate an aggregate complaint/service rate greater than 35% for low oxygen purity (output oxygen below the published specification).
Identifiers
| code_info | UDI #(s): 00814470020013 (model CHSOOO) and 00814470020006 (model CHSOOOS): All serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0407-2018%22
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