FDA Device Intelligence
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Unit, Liquid-Oxygen, Portable

FDA product code BYJ · Class 2 · Anesthesiology

179
Registered devices
607
Adverse events
6
Recalls
55
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2022-10-10Caire, Inc.An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units.
2022-10-10Caire, Inc.An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units.
2022-10-10Caire, Inc.An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units.
2022-10-10Caire, Inc.An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units.
2007-10-23Caire, Inc.Moisture ingress into the electronic liquid level indicator may cause inaccurate liquid oxygen level readings. The oxygen could run out without the patient know
2006-10-04Precision Medical, Inc.Component assembly; The fill chuck is not assembled properly which may allow the device to come apart over time releasing its contents.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.