Draeger Medical, Inc. Oxylog 3000 Plus emergency and transport ventilator Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Oxylog 3000 Plus emergency and transport ventilator
Brand
Draeger Medical, Inc.
Lot Codes / Batch Numbers
Catalog No. 5704811 & 5704813, UDI-DI: 04048675398295, All Serial No.
Products Sold
Catalog No. 5704811 & 5704813; UDI-DI: 04048675398295; All Serial No.
Draeger Medical, Inc. is recalling Oxylog 3000 Plus emergency and transport ventilator due to Draeger has become aware of instances where the device stopped working when in use when transitioning from battery to AC operation.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Draeger has become aware of instances where the device stopped working when in use when transitioning from battery to AC operation.
Recommended Action
Per FDA guidance
The firm initiated recall notification of customers by mail on 06/12/2023. The Urgent Medical Device Recall Notification indicates that customers should make sure that the device's battery is always removed and reinserted/replaced after an occurrence of the "No int. battery charging, " alarm message without removing the device from the main's supply. Prior to the device being used on battery power, the device should be disconnected and reconnected to an AC main supply and verify the color indicators per the provided diagram. Devices may be used safely as long as the provided instructions are followed. Customers are to ensure all users and maintenance personnel of affected devices are made aware of this recall. Customers are to return the provided Customer Acknowledgement Card utilizing the printed QR code. A Draeger Service representative will contact customers to arrange a firmware update of the Printed Board Assembly Charger. Any questions regarding the operation of your device are to be made to Service Technical Support at 1-800-437-2437 (press 2, 2, 1). Any questions regarding this recall event are to be directed to Michael Kelhart at 267-664-1131 or mike.kelhart@draeger.com. An updated letter was sent to customers on 02/18/2025 alerting consignees that additional reports of stopped ventilation of devices already updated in which the given alarm No int. battery charging was not handled according to the IFU. As a result of these reports, it was decided to issue an Instructions for Use (IFU) supplement with the check described in the Urgent Medical Device Recall Notice dated June 2023. This IFU was provided with the letter.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026