Datex-Ohmeda Inc One Ohmeda Datex-Ohmeda S/5 and AS/3 Anesthesia Delivery Units (The S/5 units are a later version of the AS/3 units. The conversion from AS3 to S5 occurred during the summer of 2000. This change was mainly a product name change, with a slight color variation to the shade of white being used externally on the machine. There were no design or feature and function modifications when the name change occurred.) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Datex-Ohmeda S/5 and AS/3 Anesthesia Delivery Units (The S/5 units are a later version of the AS/3 units. The conversion from AS3 to S5 occurred during the summer of 2000. This change was mainly a product name change, with a slight color variation to the shade of white being used externally on the machine. There were no design or feature and function modifications when the name change occurred.)
Brand
Datex-Ohmeda Inc One Ohmeda
Lot Codes / Batch Numbers
The affected units in the United States have serial numbers between 40013635 and 40162379.
Products Sold
The affected units in the United States have serial numbers between 40013635 and 40162379.
Datex-Ohmeda Inc One Ohmeda is recalling Datex-Ohmeda S/5 and AS/3 Anesthesia Delivery Units (The S/5 units are a later version of the AS due to Anesthetic agents could be delivered at concentrations above the concentration set on the S/5 and AS/3 Anesthesia Delivery Units (ADU) having serial n. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Anesthetic agents could be delivered at concentrations above the concentration set on the S/5 and AS/3 Anesthesia Delivery Units (ADU) having serial numbers within a specified range.
Recommended Action
Per FDA guidance
Recall letters dated February 03, 2004 stated that a firm representative would contact the consignee to schedule a visit to replace software and hardware to correct the problem.
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