Reported Nov 27, 2024 · Completed

CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.

Caire, Inc.

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: Caire, Inc. · 2200 Airport Industrial Dr Ste 500 · Ball Ground, GA · 30107-4686

Is this the product you have?

  • CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.
Lot codes and dates
  • UDI-DIM766AS20010
  • Serial numbers

    739 of 739 codes

    • CBB5224380296
    • CBB5224380292
    • CBB5224380285
    • CBB5224380284
    • CBB5224380283
    • CBB5224380281
    • CBB5224380279
    • CBB5224380278
    • CBB5224380277
    • CBB5224380276
    • CBB5224380273
    • CBB5224380271
    • CBB5224380270
    • CBB5224380268
    • CBB5224380267
    • CBB5224380266
    • CBB5224380264
    • CBB5224380263
    • CBB5224380262
    • CBB5224380257
    • CBB5224380256
    • CBB5224380250
    • CBB5224380248
    • CBB5224380246
    • CBB5224380245
    • CBB5224380244
    • CBB5224380063
    • CBB5224380062
    • CBB5224380061
    • CBB5224380059
    • CBB5224380058
    • CBB5224380057
    • CBB5224380056
    • CBB5224380053
    • CBB5224380052
    • CBB5224380051
    • CBB5224380050
    • CBB5224380049
    • CBB5224380048
    • CBB5224380047
    • CBB5224380046
    • CBB5224380044
    • CBB5224380043
    • CBB5224380042
    • CBB5224380041
    • CBB5224380040
    • CBB5224380039
    • CBB5224380038
    • CBB5224380037
    • CBB5224380036
    • CBB5224380035
    • CBB5224380034
    • CBB5224380033
    • CBB5224380032
    • CBB5224380031
    • CBB5224380030
    • CBB5224380029
    • CBB5224380028
    • CBB5224380027
    • CBB5224380026
Amount recalled
739 concentrators

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Potential failure of affected units to recharge the battery of the oxygen concentrators.

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

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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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, 6:19 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.