Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i C20...
FDA Device Recall #Z-2860-2026 - Class II, June 24, 2026
Recall Summary
| Recall Number | Z-2860-2026 |
| Classification | Class II - Moderate risk |
| Date Initiated | June 24, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Maquet Critical Care AB |
| Location | Solna |
| Product Type | Devices |
| Quantity | 408 US; 11,342 OUS |
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.
Distribution Pattern
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.
Lot / Code Information
Flow-i C20 6677200 / UDI-DI 07325710001349 Flow-i C30 6677300 / UDI-DI 07325710001363 Flow-i C40 6677400 / UDI-DI 07325710001318 Flow-i C20 6888520 / UDI-DI 07325710010617 Flow-i C30 6888530 / UDI-DI 07325710010624 Flow-i C40 6888540 / UDI-DI 07325710010631 Flow-c 6887700 / UDI-DI 07325710009765 Flow-e 6887900 / UDI-DI 07325710010457 Software versions 4.8, 4.10, and 4.11.
Other Recalls from Maquet Critical Care AB
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2963-2026 | Class II | GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Mode... | Jun 30, 2026 |
| Z-2013-2025 | Class I | Servo-u Ventilator System. Model Number: 6688600. | May 30, 2025 |
| Z-2014-2025 | Class I | Servo-n Ventilator System. Model Number: 6694800. | May 30, 2025 |
| Z-2015-2025 | Class I | Servo-u MR Ventilator System. Model Number: 688... | May 30, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.