Caire, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0479-2025)

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 #AS200-101.

Product Classification:

Class II

Date Initiated: October 4, 2024

Date Posted: November 27, 2024

Recall Number: Z-0479-2025

Event ID: 95576

Reason for Recall:

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

Status: Completed

Product Quantity: 23 concentrators

Code Information:

UDI-DI: M766AS2001010; Serial numbers: CBB5224380888, CBB5224380868, CBB5224380846, CBB5224380842, CBB5224380298, CBB5224380295, CBB5224380282, CBB5224380251, CBB5224380011, CBB5224380010, CBB5224370651, CBB5224370598, CBB5224370445, CBB5224370431, CBB5224370420, CBB5224370230, CBB5224370227, CBB5224370191, CBB5224370185, CBB5224370168, CBB5224370165, CBB5224370009, and CBB5224350790.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated