125 series iGO2 Portable Oxygen Concentrator-indicated for… recallZ-0229-2023 · DeVilbiss Healthcare LLC · initiated Sep 19, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from DeVilbiss Healthcare LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)
FDA root cause category: Under Investigation by firm
What the company is doing
DeVilbiss notified Distributors/End Users by telephone on 9/19/22. Providers of portable oxygen concentrators, identified as recipient of affected units, were contacted asking them to return any finished good units in their possession with affected serial numbers to DeVilbiss for evaluation. A replacement unit will be provided once unit possession and shipping confirmation is received. If any unit has been supplied by the provider to an end user, the provider is being requested to contact the end user to request them to stop using the unit and to replace the unit immediately. If you have any questions, call 800-338-1988.
Recall details
- Recall number
- Z-0229-2023
- Status
- Open, Classified
- Initiated by the company
- Sep 19, 2022
- Posted by the FDA
- Nov 11, 2022
- Recalling firm
- DeVilbiss Healthcare LLC
- Quantity
- 48 units
- Product code
- CAW
- FDA submissions
- K172648
- Distribution
- US Distribution in states of: CA, FL, OH, MI, MN, NY, PA, and TX; and (Foreign) country of: Canada.
Product description
125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB
Code information (models, lots, serial numbers)
UDI: 00885304022237 S/N: New Sales D22829087DS D22829097DS D22829092DS D22829086DS D22829156DS D22901205DS D22901207DS D22829099DS D22829161DS D22901203DS D22829157DS D22829159DS D22901204DS D22901201DS D22829096DS D22826095DS D22826079DS D22826091DS D22826086DS S/N: Repair D22829087DS D22829097DS D22829092DS D22829086DS D22829156DS D22901205DS D22901207DS D22829099DS D22829161DS D22901203DS D22829157DS D22829159DS D22901204DS D22901201DS D22829096DS D22826095DS D22826079DS D22826091DS D22826086DS
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- DeVilbiss 125DDevilbiss Healthcare LLC · Generator, Oxygen, Portable2 recalls1 death3 reports
Other devices under the same FDA submission
2 devices cleared under K172648 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- DeVilbiss 125D-ARYA-XBDevilbiss Healthcare LLC · Generator, Oxygen, Portable1 recall0 reports
- DeVilbiss 125D-XBDevilbiss Healthcare LLC · Generator, Oxygen, Portable1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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