FDA Device recall Z-0229-2023
125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen
- FDA Device
- Class II
- ongoing
- Published 2022-11-23
On 2022-11-23 the FDA classified a Class II recall of 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen by Devilbiss Healthcare, citing an unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0229-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-09-19 |
| Published | 2022-11-23 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Devilbiss Healthcare |
| Distribution | CA, FL, MI, MN, NY, OH, PA, TX |
Product
125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB
Reason
An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)
Identifiers
| code_info | UDI: 00885304022237 S/N: New Sales D22829087DS D22829097DS D22829092DS D22829086DS D22829156DS D22901205DS D22901207DS…UDI: 00885304022237 S/N: New Sales D22829087DS D22829097DS D22829092DS D22829086DS D22829156DS D22901205DS D22901207DS D22829099DS D22829161DS D22901203DS D22829157DS D22829159DS D22901204DS D22901201DS D22829096DS D22826095DS D22826079DS D22826091DS D22826086DS S/N: Repair D22829087DS D22829097DS D22829092DS D22829086DS D22829156DS D22901205DS D22901207DS D22829099DS D22829161DS D22901203DS D22829157DS D22829159DS D22901204DS D22901201DS D22829096DS D22826095DS D22826079DS D22826091DS D22826086DS |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Devilbiss Healthcare
- DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
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FDA Device · Class II · 2016-07-27 · Devilbiss Healthcare - DeVilbiss Model DV5x Series CPAP units
FDA Device · Class III · 2014-07-09 · Devilbiss Healthcare - DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6'…
FDA Device · Class II · 2013-10-09 · Devilbiss Healthcare
All Devilbiss Healthcare recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0229-2023%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.