Facility

MAQUET CRITICAL CARE AB

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

Key facts

3recalls · worst Class I

1inspections · worst VAI

—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)	3002808128
Establishment type	Manufacture Medical Device
Location	ROENTGENVAGEN 2 SOLNA Stockholm, SE 17154
Registration status	Active · expires 2026
Parent company	Maquet Critical Care AB (owner-operator 8010042)
Brand names	FLOW-i 4.2

Activity by year

Recalls (3)
Inspections (1)

Devices registered here (1)

Gas-Machine, Anesthesia
Product code BSZ (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.5160

Recalls & enforcement

Class IIOngoing2026-06-30
The module did not undergo electrical safety tests and functional tests during production.
Class IIOngoing2026-06-24
Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may result in the patient receiving insufficient anesthesia and may lead to intraoperative awareness.
Class IOngoing2025-05-30
Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.

FDA inspections (1)

VAI2019-09-26
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Maquet Critical Care AB

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. “MAQUET CRITICAL CARE AB (FEI 3002808128) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002808128-maquet-critical-care-ab/

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