Caire, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1117-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3

Product Classification:

Class II

Date Initiated: March 25, 2022

Date Posted: May 25, 2022

Recall Number: Z-1117-2022

Event ID: 90011

Reason for Recall:

The device was not cleared for U.S. distribution.

Status: Terminated

Product Quantity: 2 oxygen concentrators

Code Information:

Serial numbers CBB5221200337 and CBB5221200287.

Distribution Pattern:

Distribution was made to Puerto Rico. There was no foreign/government/military distribution.

Voluntary or Mandated:

Voluntary: Firm initiated