The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0481-2025·Announced 2024-11-27

CAIRE FreeStyle Comfort portable oxygen concentrator battery recharge failure

Caire Inc. is recalling 26 CAIRE FreeStyle Comfort portable oxygen concentrators due to potential battery recharge failure. Affected units identified by serial number may not charge properly.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 FDA recall of a critical medical device. The battery recharge failure creates a risk of harm to oxygen-dependent patients. As a risk-of-harm product without reported illness or injury, it meets the rubric criterion for severity score 3.

Plain-English summary

Caire Inc. is recalling 26 CAIRE FreeStyle Comfort portable oxygen concentrators, model AS200-2. The FDA has classified this as a Class II recall with recall number Z-0481-2025.

The defect involves a potential failure of the battery to recharge properly. The 26 affected units are identified by specific serial numbers and have been distributed worldwide, including throughout the United States (including Puerto Rico), Israel, and Peru.

Without proper battery recharge capability, the oxygen concentrators may not function reliably when powered by battery, affecting patients who depend on these devices for oxygen therapy.

The recalled product

Product
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.
Manufacturer
Caire, Inc.
Category
Medical Device — Oxygen Therapy Equipment
Hazard
Affected units
26

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)

  • No UDI-DI (for export only)
  • Serial numbers: CBB5224350777
  • CBB5224350774
  • CBB5224350743
  • CBB5224350723
  • CBB5224350710
  • CBB5224350653
  • CBB5224350648
  • CBB5224350636
  • CBB5224350606
  • CBB5224350583
  • CBB5224350580
  • CBB5224350575
  • CBB5224350573
  • CBB5224350567
  • CBB5224350512
  • CBB5224350510
  • CBB5224350509
  • CBB5224350508
  • CBB5224350498

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.

See all →

Same hazard · battery failure

See all →

Similar recalls