Food, drugs, devices › Caire, Inc.
Device recall: CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
Caire, Inc. (Ball Ground, GA) initiated this device recall on 25 Mar 2022; FDA lists 1 product record under event 90011, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Terminated, terminated 5 Oct 2023. Initiation: voluntary: firm initiated. Caire, Inc. has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Caire, Inc., Ball Ground, GA.
Reason for recall
"The device was not cleared for U.S. distribution."
Distribution
"Distribution was made to Puerto Rico. There was no foreign/government/military distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1117-2022 | CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3 | 2 oxygen concentrators | Class II | Terminated | 25 May 2022 |
Context
Other enforcement events for Caire, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 4 Oct 2024 | CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1. | Device | Class II | 4 |
| 10 Oct 2022 | CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit | Device | Class I | 4 |
| 21 Nov 2019 | CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intende | Device | Class II | 1 |
| 16 Sep 2019 | SAROS Oxygen System Model 3000 | Device | Class II | 1 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The device was not cleared for U.S. distribution."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Distribution was made to Puerto Rico. There was no foreign/government/military distribution."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 5 Oct 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.