CLASS II ONGOING Device recall · Reported 12 Aug 2026 · FDA Enforcement Report

Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 recalled

Maquet Critical Care AB is recalling Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i, distributed nationwide in the US. The recall was initiated on 24 Jun 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesFlow-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.

Quantity recalled408 US; 11,342 OUS

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2860-2026
FDA event ID: 99359
Recalling firm: Maquet Critical Care AB, Solna
Classification: Class II
Status: Ongoing
Recall initiated: 24 Jun 2026
FDA classified: 3 Aug 2026
Reported: 12 Aug 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

24 Jun 2026	Recall initiated by company
3 Aug 2026	Classified by FDA	+40 days
12 Aug 2026	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Alabama Arkansas California Colorado District of Columbia Delaware Florida Georgia Indiana Massachusetts Michigan Missouri New York Ohio Oregon Pennsylvania South Carolina Texas Virginia Washington

Questions about this recall

Why was it recalled?

Which lots are affected?

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.

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Maquet Critical Care AB

All 5

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Device	CLASS II	Getinge Y Sensor Module, Servo-u, Servo recalled	Maquet Critical Care AB	Device Malfunction	Nationwide
9 Jul 2025Device	CLASS I	Servo-u MR Ventilator System recalled by Maquet Critical Care AB	Maquet Critical Care AB	Labeling Errors	Nationwide
9 Jul 2025Device	CLASS I	Servo-n Ventilator System recalled by Maquet Critical Care AB	Maquet Critical Care AB	Labeling Errors	Nationwide
9 Jul 2025Device	CLASS I	Servo-u Ventilator System recalled by Maquet Critical Care AB	Maquet Critical Care AB	Labeling Errors	Nationwide

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All 13,857

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30 Sep 2026Device	CLASS II	SmartPath to dStream for XR and 3.0T recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS II	Achieva 1.5T, Achieva 1.5T Conversion recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS II	Medline Convenience Kits: Mfc Craniotomy Pack recalled	Medline Industries	Other	Nationwide