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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Device
Medical Devices/Home Healthcare

CAIRE FreeStyle Comfort Oxygen Concentrators Recalled for Battery Charging Failure

Agency Publication Date: November 15, 2024
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Summary

Caire, Inc. is recalling 794 units of the CAIRE FreeStyle Comfort portable oxygen concentrator (models AS200-1, AS200-101, AS200-103, and AS200-2). The recalled units may fail to recharge their batteries, which could cause a sudden loss of oxygen therapy for users relying on the device. No incidents or injuries have been reported, but patients could face health complications if their oxygen supply is interrupted.

Risk

If the concentrator fails to recharge its battery, the device will eventually shut down and stop delivering oxygen. This poses a significant health risk to patients who require consistent oxygen therapy, potentially leading to respiratory distress or other medical emergencies.

What You Should Do

  1. This recall affects CAIRE FreeStyle Comfort portable oxygen concentrator models AS200-1, AS200-101, AS200-103, and AS200-2.
  2. Check the model number and serial number printed on the device's identification label to determine if your unit is affected. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately to ensure your oxygen therapy is not interrupted by a battery failure.
  4. Contact the manufacturer, Caire, Inc., or your medical equipment distributor to arrange for a return, replacement, or correction of the device.
  5. If you have health concerns related to your oxygen supply, contact your healthcare provider for further instructions.
  6. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for more information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: CAIRE FreeStyle Comfort portable oxygen concentrator (AS200-1)
Model / REF:
AS200-1
Serial Numbers (740):
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
UDI:
M766AS20010

Recall #: Z-0478-2025; Quantity: 739 concentrators

Product: CAIRE FreeStyle Comfort portable oxygen concentrator (AS200-101)
Model / REF:
AS200-101
Serial Numbers:
CBB5224380888
CBB5224380868
CBB5224380846
CBB5224380842
CBB5224380298
CBB5224380295
CBB5224380282
CBB5224380251
CBB5224380011
CBB5224380010
CBB5224370651
CBB5224370598
CBB5224370445
CBB5224370431
CBB5224370420
CBB5224370230
CBB5224370227
CBB5224370191
CBB5224370185
CBB5224370168
CBB5224370165
CBB5224370009
CBB5224350790
UDI:
M766AS2001010

Recall #: Z-0479-2025; Quantity: 23 concentrators

Product: CAIRE FreeStyle Comfort portable oxygen concentrator (AS200-103)
Model / REF:
AS200-103
Serial Numbers:
CBB5224350751
CBB5224350720
CBB5224350604
CBB5224350601
CBB5224350598
CBB5224350582

Recall #: Z-0480-2025; For export only; Quantity: 6 concentrators

Product: CAIRE FreeStyle Comfort portable oxygen concentrator (AS200-2)
Model / REF:
AS200-2
Serial Numbers:
CBB5224350777
CBB5224350774
CBB5224350743
CBB5224350723
CBB5224350710
CBB5224350653
CBB5224350648
CBB5224350636
CBB5224350606
CBB5224350583
CBB5224350580
CBB5224350575
CBB5224350573
CBB5224350567
CBB5224350512
CBB5224350510
CBB5224350509
CBB5224350508
CBB5224350498
CBB5224350492
CBB5224350490
CBB5224350475
CBB5224350474
CBB5224350468
CBB5224350460
CBB5224350459

Recall #: Z-0481-2025; For export only; Quantity: 26 concentrators

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95576
Status: Resolved
Manufacturer: Caire, Inc.
Sold By: Authorized medical equipment distributors; Caire, Inc.
Manufactured In: United States
Units Affected: 4 products (739 concentrators; 23 concentrators; 6 concentrators; 26 concentrators)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.