The Recall Desk
HighFDA (Devices)·Z-0479-2025·Announced 2024-11-27

CAIRE FreeStyle Comfort Portable Oxygen Concentrator Battery Charging Failure

CAIRE FreeStyle Comfort portable oxygen concentrators may fail to recharge their batteries, potentially leaving patients without access to supplemental oxygen. Twenty-three units have been recalled.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of a life-sustaining medical device with no reported injuries or illnesses. The potential for battery charging failure creates risk of harm to patients dependent on supplemental oxygen, but injury has not yet been reported, meeting the rubric criterion for High severity.

Plain-English summary

Caire, Inc. is recalling 23 CAIRE FreeStyle Comfort portable oxygen concentrators (model AS200-101) due to potential failure of affected units to recharge their batteries. If the battery fails to recharge, the device may become unusable for patients who depend on it for supplemental oxygen.

The affected units have been distributed worldwide, including throughout the United States, Puerto Rico, Israel, and Peru. Patients and healthcare providers who have received these devices should verify their device serial numbers against the FDA's recall notice.

If you have one of the affected units, contact Caire, Inc. immediately or report any adverse events to the FDA. Do not rely on the device if battery charging is not working properly.

The recalled product

Product
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.
Manufacturer
Caire, Inc.
Category
Medical Device — Oxygen Concentrator
Hazard
Affected units
23

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • UDI-DI: M766AS2001010
  • Serial numbers: CBB5224380888
  • CBB5224380868
  • CBB5224380846
  • CBB5224380842
  • CBB5224380298
  • CBB5224380295
  • CBB5224380282
  • CBB5224380251
  • CBB5224380011
  • CBB5224380010
  • CBB5224370651
  • CBB5224370598
  • CBB5224370445
  • CBB5224370431
  • CBB5224370420
  • CBB5224370230
  • CBB5224370227
  • CBB5224370191
  • CBB5224370185

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 4 recalled by Caire, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Caire, Inc.

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Same hazard · charging failure

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