FDA recall, , Moderate risk
Maquet Flow Anesthesia Machines
Events observed where anesthetic agent was not delivered when the vaporizer was activated.
Summary by Recall Canary from the FDA notice
What happened
Maquet Critical Care AB, of Solna, Sweden, recalled its Flow Anesthesia Machine models 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, and Flow-e 6887900. The FDA added the recall to its Enforcement Report on August 3, 2026, and the company began the recall on June 24, 2026. The recall covers 408 US and 11,342 OUS.
The recall was issued because events were observed where anesthetic agent was not delivered when the vaporizer was activated, which may result in the patient receiving insufficient anesthesia and may lead to intraoperative awareness. The distribution was worldwide, with 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.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
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
- UDI-DI
- 07325710001349
- 07325710001363
- 07325710001318
- 07325710010617
- 07325710010624
- 07325710010631
- 07325710009765
- 07325710010457
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution to the states of Alabama, Arkansas, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Indiana, Massachusetts, Michigan, Missouri, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Washington, West Virginia.
- Company
- Maquet Critical Care ABSolna, Sweden
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99359
- Recall number
- Z-2860-2026
- Quantity recalled
- 408 US; 11,342 OUS
All recalls from Maquet Critical Care AB
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
