Caire, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0481-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.

Product Classification:

Class II

Date Initiated: October 4, 2024

Date Posted: November 27, 2024

Recall Number: Z-0481-2025

Event ID: 95576

Reason for Recall:

Potential failure of affected units to recharge the battery of the oxygen concentrators.

Status: Completed

Product Quantity: 26 concentrators

Code Information:

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, CBB5224350492, CBB5224350490, CBB5224350475, CBB5224350474, CBB5224350468, CBB5224350460, and CBB5224350459.

Distribution Pattern:

Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru.

Voluntary or Mandated:

Voluntary: Firm initiated