Solna, Sweden
Maquet Critical Care AB recalls
3 recalls recorded since 2018, most recently on 30 June 2026. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)3
Terminated or completed0
Class I (FDA)1
Ongoing Class II Medical devices
- Recall started
- 30 June 2026
- Reason
- The module did not undergo electrical safety tests and functional tests during production.
- Distribution
- US Nationwide distribution in the states of CA, GA, MN, NY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2963-2026
- GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; part of the SERVO-U/-N continuous ventilator system, for facility use. Maquet Critical Care AB, is a subsidiary of Getinge.
Ongoing Class II Medical devices
- Recall started
- 24 June 2026
- Reason
- 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.
- Distribution
- Worldwide - US Nationwide distribution to the states of AL, AR, CA, CO, DC, DE, FL, GA, IN, MA, MI, MO, NY, OH, OR, PA, SC, TX, VA, WA, WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2860-2026
- Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i C20 6888520 Flow-i C30 6888530 Flow-i C40 6888540 Flow-c 6887700 Flow-e 6887900
Ongoing Class I Medical devices
- Recall started
- 30 May 2025
- Reason
- 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.
- Distribution
- US Nationwide distribution and Puerto Rico. No international distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2013-2025, Z-2014-2025, Z-2015-2025
- Servo-u Ventilator System. Model Number: 6688600.
- Servo-n Ventilator System. Model Number: 6694800.
- Servo-u MR Ventilator System. Model Number: 6888800.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.