Reported May 10, 2023 · Ongoing

DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR

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?

  • DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
Lot codes and dates

8 of 8 products

Products covered by this recall
Model / numberBarcodesProduct as published
1025DS00885304000846UDI-DI: 00885304000846
Serial Numbers A175230001DS to A232160185DS
1025UK00885304022480UDI-DI: 00885304022480
Serial Numbers A179210001US to A232060432US
1025KS00853040224734UDI-DI: 00853040224734
Serial Numbers A176060001KS to A232220085KS
1025KS-AR00853040224734UDI-DI: 00853040224734
Serial Numbers A216240003KS to A229210010KR
Amount recalled
143,397 units

Where it was sold

  • Nationwide

Why it was recalled

The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard.

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, 7:38 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.