DeviceSignal · Recall classified
Maquet Critical Care AB
FDA classified a device recall on 2026-08-03 · Class II · Z-2860-2026
EventRecall classified
Effective2026-08-03
ClassificationClass II
On 2026-08-03 the FDA classified a device recall from Maquet Critical Care AB as Class II. Product: Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400…. Recall Z-2860-2026. The firm initiated it on 2026-06-24. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2860-2026
- Classification
- Class II
- Classified on
- 2026-08-03
- Initiated on
- 2026-06-24
- Firm
- Maquet Critical Care AB
- Reason
- 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.
- 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
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-2860-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
74e529a41c1b4e73baa23e8d972a69c2c7795bfff27ac56ca6e268016057ee3c- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)