Recall Z-2860-2026 ยท BSZ Gas-Machine, Anesthesia
Maquet Critical Care AB
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
| Date | Aug 3, 2026 (initiated Jun 24, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | On June 24, 2026, the firm began issuing "Urgent Medical Device Correction" letters via FedEx to customers at the Risk Manager level. Customers were informed that according to the Instructions for Use, this indication signifies that concentration levels are below detectable limits, serving as confirmation that no agent is present: **/gas analyzer has no information to display Customers were given recommended precautions to identify and mitigate the issue, such as confirming that the anesthetic agent is being delivered after activating the vaporizer, and continuously monitoring end-tidal anes |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191027 | Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System Maquet Critical Care AB, Mar 18, 2020 |