Maquet Critical Care AB
3 recall(s) on record — most severe on record: Class I.
Recalls by year
- Recalls (3)
Registered facilities (1)
- MAQUET CRITICAL CARE AB FEI 3002808128 · SE
Recalls & enforcement
- Class IIOngoing2026-06-30The module did not undergo electrical safety tests and functional tests during production.
- Class IIOngoing2026-06-24Events 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 IOngoing2025-05-30Potential 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.
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “Maquet Critical Care AB — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-8010042-maquet-critical-care-ab/
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