Z-0229-2023Class II

125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models...

Name: Z-0229-2023 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models...
Creator: DeVilbiss Healthcare LLC
Published: 2022-09-19
License: https://open.fda.gov/license/

Sunrise Medical, Inc. / initiated 2022-09-19 / Open, Classified / root cause: manufacturing process

FDA source

DeVilbiss Healthcare LLC began a recall of 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB on 2022-09-19. FDA classified it as Class II and gives the reason as "An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)". 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-0229-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-19
Posted: 2022-11-11
Recalling firm: Sunrise Medical, Inc.
Product: 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB
Product code: CAW Generator, Oxygen, Portable
Reason for recall: An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 48 units
Distribution: US Distribution in states of: CA, FL, OH, MI, MN, NY, PA, and TX; and (Foreign) country of: Canada.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0229-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0229-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-23	2022-11-11

Product code CAW

K172648Class IIDrive DeVilbiss iGo 2 Portable Oxygen ConcentratorDevilbiss Healthcare, LLC / cleared 2018-03-23

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)