Agency classClass IIOur severity:High FDA (Devices)·Z-0481-2026·Announced 2025-11-19

Oxygen concentrator batteries recalled over a chip that can stop oxygen

Philips Respironics is recalling 56 SimplyGo Mini standard battery kits because a defective chip can make the battery fail, shutting down the concentrator and stopping oxygen delivery.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Scored 3 under the risk-of-harm criterion: a battery fault that shuts down an oxygen concentrator interrupts therapy, and no injuries are reported.

Plain-English summary

The SimplyGo Mini Standard Battery Kit, product code 1116816, sold as an accessory for the SimplyGo Mini Portable Oxygen Concentrator (product code 1113600), is being recalled.

Certain serial numbers of the 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. Philips states that 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, and that this may happen at a temperature within the specified operating range.

The recall covers 56 units, of which the record lists 55 in the United States and 1 outside it, carrying UDI-DI 00606959032385, distributed in Georgia, Idaho, Kentucky, New Jersey and New York and to Canada. The FDA has classified the action as Class II.

The enforcement record reports no injuries. Users should check their battery serial number and follow Philips Respironics' instructions.

The recalled product

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
Manufacturer: Philips Respironics, Inc.
Category: Medical Device — Oxygen concentrator
Hazard: battery-failure
oxygen-interruption
defective-chip

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Product Code: 1116816
UDI-DI: 00606959032385
Serial Numbers: 2438V115830
2438V115960
2438V116033
2438V115899
2438V115832
2438V115964
2438V116034
2438V115837
2438V115965
2438V116040
2438V115840
2438V115967
2438V116044
2438V115842
2438V115968
2438V116045
2438V115844
2438V115970

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Same manufacturer · Philips Respironics, Inc.

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