# FDA recall Z-0481-2026

> **Philips Respironics, Inc.** · Class II · device recall initiated 2025-10-07.

## Product

SimplyGo Mini, Standard Battery Kit;  Product code: 1116816;    The affected battery kits are sold as accessories for the SimplyGo Mini:  SimplyGo Mini Portable Oxygen Concentrator  Product code: 1113600

## Reason for recall

Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the battery to either fail to charge or lose voltage output when in use in the device.  If the fault occurs while the device is running on battery power, the SimplyGo Mini will shut down and stop providing oxygen to the user.  This may happen at a temperature within the specified operating temperature range of the SimplyGo Mini.

## Distribution

US Nationwide distribution in the states of GA, ID, KY, NJ, NY and the country of Canada.

## Key facts

- **Recall number:** Z-0481-2026
- **Recalling firm:** Philips Respironics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-07
- **Report date:** 2025-11-19

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0481-2026

## Citation

> AI Analytics. FDA recall Z-0481-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0481-2026. Source: US FDA. Licensed CC0.

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