125 series iGO2 Portable Oxygen Concentrator-indicated for the… — Class II medical device recall Z-0229-2023
Ongoing recall by DeVilbiss Healthcare LLC, reported 2022-11-23, distributed in CA, FL, MI, MN, NY, OH, PA, TX. An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathwa
| Recall number | Z-0229-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeVilbiss Healthcare LLC, Somerset, PA, United States |
| Recall initiated | 2022-09-19 |
| Classified | 2022-11-11 |
| Reported by FDA | 2022-11-23 |
| Distributed | CA, FL, MI, MN, NY, OH, PA, TX |
| Countries outside the US | CA |
| Quantity | 48 units |
| Reason classes | unapproved product |
| UPC / GTIN / UDI-DI | 00885304022237 |
| Model numbers | 125D, 125D-XB |
Product
125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB
Reason for recall
An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)
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-0229-2023. 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.