Data Foundry

Medical device recalls 2025

SimplyGo Mini — Class II medical device recall Z-0481-2026

Ongoing recall by Philips Respironics, Inc., reported 2025-11-19, distributed nationwide. Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the b

Recall numberZ-0481-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmPhilips Respironics, Inc., Murrysville, PA, United States
Recall initiated2025-10-07
Classified2025-11-07
Reported by FDA2025-11-19
DistributedNationwide (US)
Countries outside the USCA
UPC / GTIN / UDI-DI00606959032385
Serial numbers2438V115830, 2438V115832, 2438V115837, 2438V115840, 2438V115842, 2438V115844, 2438V115878, 2438V115890, 2438V115894, 2438V115895, 2438V115896, 2438V115897, 2438V115899, 2438V115919, 2438V115937, 2438V115939, 2438V115942, 2438V115948, 2438V115957, 2438V115960, 2438V115964, 2438V115965, 2438V115967, 2438V115968, 2438V115970 and 31 more

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0481-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.