Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0481-2026 — 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

U.S. FDA — Device Enforcement · United States · 2025-10-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0481-2026
Date of alert
2025-10-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips Respironics, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00606959032385
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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