---
title: "CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense... — FDA record Z-1117-2022 | Is It on Recall"
description: "The device was not cleared for U.S. distribution."
url: https://isitonrecall.com/recall/fda-device-z-1117-2022-caire-freestyle-comfort-portable-oxygen-concentrator-with-autosat-ultrasense-and-autodose-model-as20/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3 — FDA record Z-1117-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Mar 25, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
- **Reason**: The device was not cleared for U.S. distribution.
- **Classification**: Class II
- **Recalling firm**: Caire, Inc.
- **Quantity**: 2 oxygen concentrators
- **Agency-reported status**: Terminated
- **Source record identifier**: Z-1117-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1117-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Serial numbers CBB5221200337 and CBB5221200287. |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

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

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: May 25, 2022
- **Recall initiation date**: Mar 25, 2022
- **Center classification date**: May 19, 2022
- **Termination date**: Oct 5, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1117-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Caire, Inc. records](https://isitonrecall.com/brand/caire-inc/)