# FDA recall Z-0229-2023

> **DeVilbiss Healthcare LLC** · Class II · device recall initiated 2022-09-19.

## 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)

## Distribution

US Distribution in states of: CA, FL, OH, MI, MN, NY, PA, and TX; and (Foreign) country of: Canada.

## Key facts

- **Recall number:** Z-0229-2023
- **Recalling firm:** DeVilbiss Healthcare LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-09-19
- **Report date:** 2022-11-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Somerset, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0229-2023

## Citation

> AI Analytics. FDA recall Z-0229-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0229-2023. Source: US FDA. Licensed CC0.

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