Class II U.S. Food and Drug Administration

Maquet Critical Care AB Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 recall: Events observed where anesthetic agent was not delivered when the vaporizer

Recall published 2 months ago

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.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2860-2026
Published
August 12, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Maquet Critical Care AB
Product type
Medical devices
Units affected
408 US; 11,342 OUS
Distribution
Nationwide
Made in
Sweden
Lot / code info
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.
UPC codes
07325710001349, 07325710001363, 07325710001318, 07325710010617, 07325710010624, 07325710010631, 07325710009765, 07325710010457

Products covered by this recall

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

Check your product

The notice names 8 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 07325710001349
  • 07325710001363
  • 07325710001318
  • 07325710010617
  • 07325710010624
  • 07325710010631
  • 07325710009765
  • 07325710010457

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Maquet Critical Care AB — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Maquet Critical Care AB — Rontgenvagen 2, Solna

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Maquet Critical Care AB medical devices 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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 07325710001349, 07325710001363, 07325710001318. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

Related recalls