Caire, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0480-2025)

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 #AS200-103.

Product Classification:

Class II

Date Initiated: October 4, 2024

Date Posted: November 27, 2024

Recall Number: Z-0480-2025

Event ID: 95576

Reason for Recall:

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

Status: Completed

Product Quantity: 6 concentrators

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated