Facility

CAIRE Medical Technology (Chengdu) Co., Ltd.

5 recall(s) on record — most severe on record: Class I.

Key facts

5recalls · worst Class I

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3009550619
Establishment type	Manufacture Medical Device
Location	1/F, Building 4, No. 670 Haifa Road Chengdu Sichuan, CN 61113
Registration status	Active · expires 2026
Parent company	CAIRE Inc. (owner-operator 9008476)
Brand names	VisionAire 5; VisionAire 3; VisionAire V; VisionAire 2; NewLife Elite; VisionAire

Activity by year

Recalls (5)

Devices registered here (1)

Generator, Oxygen, Portable
Product code CAW (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.5440

Recalls & enforcement

Class IICompleted2024-10-04
Potential failure of affected units to recharge the battery of the oxygen concentrators.
Class ITerminated2022-10-10
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.
Class IITerminated2022-03-25
The device was not cleared for U.S. distribution.
Class IITerminated2019-11-21
Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US..
Class IITerminated2019-09-16
There is an electronics control issue that causes the unit to not power on with battery power only.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “CAIRE Medical Technology (Chengdu) Co., Ltd. (FEI 3009550619) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009550619-caire-medical-technology-chengdu-co-ltd/

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