Recall archive / FDA device enforcement
SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for the... — FDA record Z-0481-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 7, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Recalling firm
- Philips Respironics, Inc.
- Quantity
- 56 units (55 US, 1 OUS)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0481-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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; |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the states of GA, ID, KY, NJ, NY and the country of Canada.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Nov 19, 2025
- Recall initiation date
- Oct 7, 2025
- Center classification date
- Nov 7, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.