Recall Z-2860-2026— Maquet Critical Care AB
Class II · Ongoing
Class II FDA medical device recall by Maquet Critical Care AB, initiated 2026-06-24. It names one FDA 510(k) clearance: K191027. Product: 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. 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..
- Recalling firm
- Maquet Critical Care AB
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-06-24
- Firm location
- Solna, Sweden
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.