# FDA recall Z-0724-2023

> **DeVilbiss Healthcare LLC** · Class II · device recall initiated 2022-11-18.

## Product

DeVilbiss, 525 5-liter Oxygen Concentrator  Models 525DS, 525DS-Q

## Reason for recall

The firm has received complaints of the device becoming hot. The firm has updated the user manual to include warnings that applied parts in contact with the patient may in some situations exceed 41 degrees Celsius (105.8 degrees Fahrenheit), clarification on expected service life, and the need for maintenance to certain components.

## Distribution

US Nationwide. Foreign distribution pending.

## Key facts

- **Recall number:** Z-0724-2023
- **Recalling firm:** DeVilbiss Healthcare LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-11-18
- **Report date:** 2022-12-28

- **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-0724-2023

## Citation

> AI Analytics. FDA recall Z-0724-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0724-2023. Source: US FDA. Licensed CC0.

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