Device recall: CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.
Class II FDA enforcement event 95576. Recall start date: . Status in the FDA record: Completed.
Reason for recall, in the words of FDA
Potential failure of affected units to recharge the battery of the oxygen concentrators.
Class II, in the words of FDA
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
Caire, Inc. started this device recall on 4 Oct 2024. The firm address in the FDA record is in Ball Ground, GA. FDA put the recall in Class II. FDA event 95576 has 4 product records. The first FDA enforcement report date is 27 Nov 2024. The record gives the status Completed.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru.
Recalling firm
Caire, Inc., Ball Ground, GA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
4 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0478-2025 | CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1. | 739 concentrators | Class II | Completed | 27 Nov 2024 |
| Z-0479-2025 | CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101. | 23 concentrators | Class II | Completed | 27 Nov 2024 |
| Z-0480-2025 | CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103. | 6 concentrators | Class II | Completed | 27 Nov 2024 |
| Z-0481-2025 | CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2. | 26 concentrators | Class II | Completed | 27 Nov 2024 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2024
- 970
- Share of these events in Class II
- 87%
- Product records in this event
- 4Median of the firm: 1
- Events of the firm on the register
- 5
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 10 Oct 2022 | CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit | Device | Class I | 4 |
| 25 Mar 2022 | CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3 | Device | Class II | 1 |
| 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 |
Official channels
- FDA enforcement report Z-0478-2025The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 95576. https://recallregister.com/fda/ii/95576/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru.
- What quantity of product is in FDA event 95576?
- The event has 4 product records. The first record gives this quantity:
739 concentrators
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2024 have the same class?
- 87% of the 970 device events that started in 2024 are in Class II.