DeVilbiss Healthcare LLC 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB
Brand
DeVilbiss Healthcare LLC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
DeVilbiss Healthcare LLC is recalling 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen due to An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway). Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL, IN, MI, MN, NY, OH, PA, TX
Page updated: Jan 10, 2026