Class II — Maquet Critical Care AB
| Recalling firm | Maquet Critical Care AB |
|---|---|
| Registered facility | MAQUET CRITICAL CARE AB (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| 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 |
| Quantity | 408 US; 11,342 OUS |
| 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 | 2026-06-24 |
| Classified | 2026-08-03 |
| Recall number | Z-2860-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Maquet Critical Care AB (Z-2860-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99359/
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