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CLASS II · ModerateFDA

Philips Respironics, Inc. recalls SimplyGo Mini

📅 Oct 7, 2025 · 📍 Nationwide
Recalling company
Philips Respironics, Inc.
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
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.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Oct 7, 2025
Reported
Nov 19, 2025
Distribution
US Nationwide distribution in the states of GA, ID, KY, NJ, NY and the country of Canada.
Status
Ongoing
Quantity
56 units (55 US, 1 OUS)
Lot / codes
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, 2438V116046, 2438V115878, 2438V115972, 2438V116047, 2438V115890, 2438V115973, 2438V116048, 2438V115894, 2438V115974, 2438V116049, 2438V115895, 2438V115980, 2438V116050, 2438V115896, 2438V115981, 2438V116051, 2438V115897, 2438V115983, 2438V116052, 2438V115919, 2438V115984, 2438V116226, 2438V115937, 2438V115991, 2438V116229, 2438V115939, 2438V115992, 2438V116233, 2438V115942, 2438V115993, 2438V116249, 2438V115948, 2438V115994, 2438V116253, 2438V115957, 2438V115995, 2438V116258, 2438V117762;
Company location
Murrysville, PA
Recall type
Voluntary: Firm initiated
Recall number
Z-0481-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0481-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.