Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported November 19, 2025
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
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Philips Respironics, Inc. recalled SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits… - a moderate-severity action.
SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits… was recalled by Philips Respironics, Inc. in November 19, 2025. Reason: Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the …. Check the official notice for the remedy. Verify recall #Z-0481-2026 with the FDA Devices before acting.
The recall
Philips Respironics, Inc. issued this moderate-severity FDA Devices recall-Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the ….
- Moderate
- severity level
- 56 units
- affected scope
- Class II
- classification
- November 19, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0481-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0481-2026) was formally reported on November 19, 2025, with the manufacturer initiating the action on October 7, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Philips Respironics, Inc. is listed as the recalling firm, operating out of Murrysville, PA. Federal records list the affected scope as 56 units (55 US, 1 OUS).
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of GA, ID, KY, NJ, NY and the country of Canada.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
56 units (55 US, 1 OUS)
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0481-2026 |
| Date reported | November 19, 2025 |
| Date initiated | October 7, 2025 |
| Recalling firm | Philips Respironics, Inc. |
| Firm location | Murrysville, PA |
| Affected scope | 56 units (55 US, 1 OUS) |
| Distribution | US Nationwide distribution in the states of GA, ID, KY, NJ, NY and the country of Canada. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0481-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Philips Respironics, Inc.. Units affected: 56 units (55 US, 1 OUS).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 19, 2025. Severity: Moderate. Recall number: Z-0481-2026.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the states of GA, ID, KY, NJ, NY and the country of Canada..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0481-2026) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 19, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.