Reported Nov 23, 2022 · Ongoing

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

DeVilbiss Healthcare LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: DeVilbiss Healthcare LLC · 100 Devilbiss Dr · Somerset, PA · 15501-2125

Is this the product you have?

  • 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen
  • Models
    • 125D
    • 125D-XB
Lot codes and dates
  • UDI00885304022237
  • S/NNew Sales
    • D22829087DS
    • D22829097DS
    • D22829092DS
    • D22829086DS
    • D22829156DS
    • D22901205DS
    • D22901207DS
    • D22829099DS
    • D22829161DS
    • D22901203DS
    • D22829157DS
    • D22829159DS
    • D22901204DS
    • D22901201DS
    • D22829096DS
    • D22826095DS
  • D22826079DS D22826091DS D22826086DS S/NRepair
    • D22829087DS
    • D22829097DS
    • D22829092DS
    • D22829086DS
    • D22829156DS
    • D22901205DS
    • D22901207DS
    • D22829099DS
    • D22829161DS
    • D22901203DS
    • D22829157DS
    • D22829159DS
    • D22901204DS
    • D22901201DS
    • D22829096DS
    • D22826095DS
    • D22826079DS
    • D22826091DS
    • D22826086DS
Amount recalled
48 units

Where it was sold

Why it was recalled

An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.