Flow Anesthesia Machines Recalled for Failure to Deliver Anesthetic Agent
The FDA is recalling Flow Anesthesia Machines because events occurred where the anesthetic agent was not delivered when the vaporizer was activated, potentially causing patients to receive insufficient anesthesia.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device (anesthesia machine) where the anesthetic agent was not delivered upon activation, creating a risk of insufficient anesthesia and potential intraoperative awareness. Per the severity rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, which corresponds to a High severity rating.
Plain-English summary
The U.S. Food and Drug Administration is recalling several models of Flow Anesthesia Machines (Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e) manufactured by Maquet Critical Care AB. The recall is due to documented events where the anesthetic agent was not delivered when the vaporizer was activated, which may result in patients receiving insufficient anesthesia and experiencing intraoperative awareness.
These devices are used in surgical settings to administer anesthesia during procedures. The failure to deliver the intended anesthetic agent poses a direct risk of inadequate anesthesia, which can compromise patient safety and increase the likelihood of awareness during surgery. Consumers and healthcare facilities that operate these machines should cease use until the recall is resolved and follow FDA instructions for obtaining replacement units or further guidance.
The recall affects worldwide distribution including United States states such as Alabama, Arkansas, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Indiana, Massachusetts, Michigan, Missouri, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Washington, and West Virginia. The manufacturer, Maquet Critical Care AB, is responsible for addressing this recall through its designated channels.
The recalled product
- 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
- Manufacturer
- Maquet Critical Care AB
- Category
- Medical Device
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- 4.10
- and 4.11.
Distribution
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