Class IOngoingZ-0934-2026
Draeger, Inc. recalls Draeger Vapor 3000. Unheated
A certain component of affected devices was not delivered within specification and contained impurities.
Draeger, Inc.PADec 31, 2025
Class I recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 217–228 of 595 recalls
Class IOngoingZ-0933-2026
Draeger, Inc. recalls Draeger Vapor 2000. Unheated
A certain component of affected devices was not delivered within specification and contained impurities.
Draeger, Inc.PADec 31, 2025
Class IOngoingZ-0915-2026
GE Medical Systems China Co., Ltd. recalls GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replacea…
Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure.…
GE Medical Systems Chi…Dec 24, 2025
Class IOngoingZ-0914-2026
GE Medical Systems China Co., Ltd. recalls GE Healthcare Carestation anesthesia system
Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure.…
GE Medical Systems Chi…Dec 24, 2025
Class IOngoingZ-0913-2026
GE Medical Systems China Co., Ltd. recalls GE Healthcare Carestation anesthesia system
Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure.…
GE Medical Systems Chi…Dec 24, 2025
Class IOngoingZ-0885-2026
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS)
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
Fresenius Kabi USA, LL…MADec 24, 2025
Class IOngoingZ-0593-2026
Draeger, Inc. recalls ErgoStar CM 60
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Draeger, Inc.PADec 17, 2025
Class IOngoingZ-0592-2026
Draeger, Inc. recalls ErgoStar CM 55
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Draeger, Inc.PADec 17, 2025
Class IOngoingZ-0591-2026
Draeger, Inc. recalls ErgoStar CM 45
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Draeger, Inc.PADec 17, 2025
Class IOngoingZ-0590-2026
Draeger, Inc. recalls ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of r…
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Draeger, Inc.PADec 17, 2025
Class IOngoingZ-0586-2026
Fresenius Kabi USA, LLC recalls IVENIX INFUSION SYSTEM
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Fresenius Kabi USA, LL…MADec 10, 2025
Class IOngoingZ-0570-2026
Olympus Corporation Of The Americas recalls Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog…
Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.
Olympus Corporation of…PADec 3, 2025