Caire Inc.

Active in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000013030 FEI 2129616

Caire Inc. is a medical device manufacturer based in the United States, with 317 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II and I; EU Class IIa) and 12 FDA recalls as of 13 Nov 2026.

Devices: 317
Registrations: EUDAMEDFDA
FDA recalls: 12

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries: FDA GUDID 267
EUDAMED 69
FDA 510(k) 6

A device listed in two registries counts in both.
Device classes: FDA Class II 246
EU Class IIa 69
FDA Class I 2
Top EMDN categories: Respiratory and anaesthesia devices - various 48
Instruments for functional explorations and therapeutic interventions 21
FDA recalls: 12 recalls matched by name
Sites and related companies: MPS Medical Product Service GmbH authorised representative
Identifiers: EUDAMED SRN US-MF-000013030
FDA FEI 2129616
DUNS 807537683

At a glance

Counted by deviCERTS from registry records

Market reach

European Union: EUDAMED actor
United States: FDA FEI, FDA recalls
Authorised rep.: MPS Medical Product Service GmbHDE

What Caire Inc. makes

Caire Inc. manufactures portable and stationary liquid oxygen units, including the Spirit Portable Liquid Oxygen system, as well as mobile and stationary oxygen concentrators like the Integra EZ and Liberator models. The company also produces medical gas flowmeters with Thorpe tubes and pulmonary function analysis systems for adults, such as the VisionAire 2. Their product line includes portable oxygen delivery solutions like the Stroller, designed for patient mobility.

The company’s devices are regulated under Class I, Class II, and Class IIa classifications, with listings in the EU’s eudamed registry, the FDA’s 510(k) clearance database, and the FDA’s Unique Device Identifier (UDI) system. Caire Inc. is headquartered in the United States.

AI-generated from registry data, 4 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue317

Newest first, rows 1-50 of 317

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Showing 1-50 of 317

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN: US-MF-000013030
FDA FEI number: 2129616
DUNS number: 807537683
EUDAMED status: Active
EUDAMED registered name: CAIRE Inc.
Registered address: 2200, Airport Industrial drive, 30107, Ball Ground, United States
Website: www.caireinc.com
Email: jack.vangaans@caireinc.com
Phone: +49 0 202 25859148
PRRC contact: Jack Van Gaans(public in EUDAMED)

FDA recalls12

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

2017 0
2018 0
2019 2
2020 0
2021 0
2022 5
2023 0
2024 4
2025 0
2026 0

1 initiated before 2017

Showing the 10 most recent of 12 recalls.

2024
- 4 Oct 2024 Z-0478-2025 Class II Completed Potential failure of affected units to recharge the battery of the oxygen concentrators. Distribution: Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru. Submission number: K020324
- 4 Oct 2024 Z-0479-2025 Class II Completed Potential failure of affected units to recharge the battery of the oxygen concentrators. Distribution: Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru. Submission number: K020324
- 4 Oct 2024 Z-0480-2025 Class II Completed Potential failure of affected units to recharge the battery of the oxygen concentrators. Distribution: Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru.
- 4 Oct 2024 Z-0481-2025 Class II Completed Potential failure of affected units to recharge the battery of the oxygen concentrators. Distribution: Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru.
2022
- 10 Oct 2022 Z-0336-2023 Class I Terminated An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units. Distribution: US Nationwide - Worldwide Distribution: CA, NC, OH, AZ, and Canada, Chile, Colombia, and Germany Submission number: K800742
- 10 Oct 2022 Z-0337-2023 Class I Terminated An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units. Distribution: US Nationwide - Worldwide Distribution: CA, NC, OH, AZ, and Canada, Chile, Colombia, and Germany Submission number: K800742
- 10 Oct 2022 Z-0338-2023 Class I Terminated An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units. Distribution: US Nationwide - Worldwide Distribution: CA, NC, OH, AZ, and Canada, Chile, Colombia, and Germany Submission number: K800742
- 10 Oct 2022 Z-0339-2023 Class I Terminated An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units. Distribution: US Nationwide - Worldwide Distribution: CA, NC, OH, AZ, and Canada, Chile, Colombia, and Germany Submission number: K800742
- 25 Mar 2022 Z-1117-2022 Class II Terminated The device was not cleared for U.S. distribution. Distribution: Distribution was made to Puerto Rico. There was no foreign/government/military distribution.
2019
- 21 Nov 2019 Z-0805-2020 Class II Terminated Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US.. Distribution: US Nationwide distribution in the states of MI, CA, CT.

Show all 12 recalls

2019
- 16 Sep 2019 Z-0248-2020 Class II Terminated There is an electronics control issue that causes the unit to not power on with battery power only. Distribution: US and Chile Submission number: K083163
2007
- 23 Oct 2007 Z-1716-2008 Unclassified (pre-2012) Terminated Moisture ingress into the electronic liquid level indicator may cause inaccurate liquid oxygen level readings. The oxygen could run out without the patient knowledge. Distribution: U.S. Nationwide and the following foreign countries: Argentina, Austria, Brazil, Canada, China, Chile, Central…
  Full distribution text
  U.S. Nationwide and the following foreign countries: Argentina, Austria, Brazil, Canada, China, Chile, Central America/Caribbean, Colombia, Costa Rica, Europe, Austria, Belgium, Denmark, France, Germany, Greece, Hungary, Irish Republic, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom, Mexico, South America, Peru and Uruguay.
  Submission number: K050153

Frequently asked questions

How many devices does CAIRE INC. have in the registry?

The registry currently lists 317 devices for CAIRE INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list CAIRE INC.'s devices?

Among its 50 most recently registered devices, CAIRE INC. has devices listed in EUDAMED (1 device) and FDA GUDID (49 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do CAIRE INC.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for CAIRE INC.'s devices are Class IIa and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for CAIRE INC.?

FDA recall records list 12 recalls initiated by CAIRE INC., the most recent initiated on 4 Oct 2024. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from CAIRE INC. in the registry?

The most recently registered devices listed for CAIRE INC. include Spirit, STROLLER 10998054, STROLLER 10564125 and STROLLER 14770508.

Generated automatically from registry data and not verified by a human reviewer.