FDA Medical devices recall ·

Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40… recall

Recall number
Z-2860-2026
Date
(initiated June 24, 2026)
Company / brand
Maquet Critical Care AB
Rontgenvagen 2, Solna, Sweden
Category
Medical devices › Class II
Classification
Class II
Status
Ongoing
Units affected
408 US; 11,342 OUS
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

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

Why was it recalled?

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.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

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.

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.

States: 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

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-2860-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.