Z-0481-2026Class II

SimplyGo Mini, Standard Battery Kit

Name: Z-0481-2026 SimplyGo Mini, Standard Battery Kit
Creator: Philips Respironics, Inc.
Published: 2025-10-07
License: https://open.fda.gov/license/

Respironics, Inc. / initiated 2025-10-07 / Open, Classified / root cause: manufacturing process

FDA source

Philips Respironics, Inc. began a recall of SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for the SimplyGo Mini: SimplyGo Mini Portable... on 2025-10-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0481-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-07
Posted: 2025-11-07
Recalling firm: 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
Product code: CAW Generator, Oxygen, Portable
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On October 7, 2025 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Actions for Distributors: Check inventory and place into quarantine any identified affected products. Complete and return the provided response form. Alert any customers who may have purchased affected products and work with them to return the affected product. A Philips representative will reach out regarding return and replacement of all affected product. Actions for patients: Check the serial numbers to verify if product affected by recall. If your product is affected, please discontinue use or the battery immediately. Contact your distributor and follow their instructions on how to receive a replacement battery and arrange for the return of the affected batteries in your possession. If the serial number on your battery kit does not match any of the affected serial numbers, then your battery is not affected by this issue and there is no need for any further action by you.
Quantity in commerce: 56 units (55 US, 1 OUS)
Distribution: US Nationwide distribution in the states of GA, ID, KY, NJ, NY and the country of Canada.
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0481-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0481-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-19	2025-11-07

Product code CAW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)