Draeger Medical, Inc. Babylog 8000 plus with software version 5.n. Neonatal Respirator-Continuous Ventilator Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Babylog 8000 plus with software version 5.n. Neonatal Respirator-Continuous Ventilator
Brand
Draeger Medical, Inc.
Lot Codes / Batch Numbers
Catalog numbers 8418300, 8411162, 8418002, and 8418000
Products Sold
Catalog numbers 8418300, 8411162, 8418002, and 8418000
Draeger Medical, Inc. is recalling Babylog 8000 plus with software version 5.n. Neonatal Respirator-Continuous Ventilator due to Failure to generate an alarm when an unintended disconnection occurrs. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failure to generate an alarm when an unintended disconnection occurrs
Recommended Action
Per FDA guidance
Recalling firm has issued a medical device recall letter to consignees to the attention of the Director, Neonatal Intensive Care Unit via Certified Mail to alert them of additional monitoring requirements if a PEEP setting of less than 2.5 mbar is used
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