The Recall Desk
HighFDA (Devices)·Z-0478-2025·Announced 2024-11-27

CAIRE FreeStyle Comfort Oxygen Concentrators Recalled for Battery Charging Failure

Caire recalls 739 FreeStyle Comfort portable oxygen concentrators that may fail to recharge their batteries. The devices were distributed in the US, Puerto Rico, Israel, and Peru.

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: This is an FDA Class II recall of a life-sustaining medical device. While no illnesses or injuries have been reported and the hazard is theoretical, oxygen concentrators are risk-of-harm products where device failure could harm patients dependent on supplemental oxygen.

Plain-English summary

Caire, Inc. is recalling 739 units of the FreeStyle Comfort portable oxygen concentrator (model AS200-1) due to a potential failure of the battery charging system in affected units.

The recalled concentrators were distributed worldwide, including throughout the United States, Puerto Rico, Israel, and Peru. For more information about this recall and instructions on device replacement or repair, users should contact the FDA or Caire, Inc.

The recalled product

Product
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.
Manufacturer
Caire, Inc.
Category
Medical Device — Portable Oxygen Concentrator
Hazard
Affected units
739

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: M766AS20010
  • Serial numbers: CBB5224380296
  • CBB5224380292
  • CBB5224380285
  • CBB5224380284
  • CBB5224380283
  • CBB5224380281
  • CBB5224380279
  • CBB5224380278
  • CBB5224380277
  • CBB5224380276
  • CBB5224380273
  • CBB5224380271
  • CBB5224380270
  • CBB5224380268
  • CBB5224380267
  • CBB5224380266
  • CBB5224380264
  • CBB5224380263
  • CBB5224380262

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 · battery charging failure

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