Class II — DeVilbiss Healthcare LLC
| Recalling firm | Drive DeVilbiss Healthcare |
|---|---|
| Registered facility | DeVilbiss Healthcare LLC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway) |
| Product | 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB |
| Quantity | 48 units |
| Distribution | US Distribution in states of: CA, FL, OH, MI, MN, NY, PA, and TX; and (Foreign) country of: Canada. |
| Initiated | 2022-09-19 |
| Classified | 2022-11-11 |
| Recall number | Z-0229-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — DeVilbiss Healthcare LLC (Z-0229-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90950/
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