FDA Device Intelligence
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Compressor, Air, Portable

FDA product code BTI · Class 2 · Anesthesiology

617
Registered devices
5,408
Adverse events
5
Recalls
74
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2023-12-29Datex-Ohmeda, Inc.GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE R860 or
2023-12-29Datex-Ohmeda, Inc.GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE R860 or
2023-12-29Datex-Ohmeda, Inc.GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE R860 or
2013-12-05Maquet Cardiovascular Us Sales, LlcMaquet Compressor Mini may deliver compressed air at a temperature higher than specified.
2007-01-26Draeger Medical, Inc.Compressors not providing sufficient supply pressure to connected medical ventilator

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