# FDA recall Z-0481-2025

> **Caire, Inc.** · Class II · device recall initiated 2024-10-04.

## Product

CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.

## Reason for recall

Potential failure of affected units to recharge the battery of the oxygen concentrators.

## Distribution

Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru.

## Key facts

- **Recall number:** Z-0481-2025
- **Recalling firm:** Caire, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2024-10-04
- **Report date:** 2024-11-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ball Ground, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0481-2025

## Citation

> AI Analytics. FDA recall Z-0481-2025. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0481-2025. Source: US FDA. Licensed CC0.

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