The Recall Desk
HighFDA (Devices)·Z-0480-2025·Announced 2024-11-27

CAIRE FreeStyle Comfort Portable Oxygen Concentrator Battery Recharge Failure

Six CAIRE FreeStyle Comfort oxygen concentrators may fail to recharge their batteries, potentially affecting portable use of these medical devices. Caire, Inc. is recalling affected units worldwide.

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 a Class II medical device recall. The hazard involves potential battery recharge failure on a portable oxygen concentrator, a life-sustaining medical device. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported receive a score of 3.

Plain-English summary

Six CAIRE FreeStyle Comfort portable oxygen concentrators (model AS200-103) are being recalled. The affected units are identified by their serial numbers: CBB5224350751, CBB5224350720, CBB5224350604, CBB5224350601, CBB5224350598, and CBB5224350582.

The recalled concentrators may fail to properly recharge their batteries. For patients who depend on these devices for respiratory support, this malfunction could affect their ability to use the device as a portable system.

These units have been distributed worldwide to the United States (including Puerto Rico), Israel, and Peru. Patients and healthcare providers should identify potentially affected units by serial number and contact Caire, Inc. for instructions regarding next steps.

The recalled product

Product
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.
Manufacturer
Caire, Inc.
Category
Medical Device — Respiratory / Oxygen Equipment
Hazard
Affected units
6

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 (7)

  • No UDI-DI (for export only)
  • Serial numbers CBB5224350751
  • CBB5224350720
  • CBB5224350604
  • CBB5224350601
  • CBB5224350598
  • and CBB5224350582.

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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