Omron Healthcare, Inc. Medication Bottle (U22-3), a component of the MicroAir Vibrating Mesh Nebulizer, Model NE-U22V/NE-22VAC; Distributed by: Omron Healthcare, Inc., 300 Lakeview Parkway, Vernon Hills, IL 60061 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medication Bottle (U22-3), a component of the MicroAir Vibrating Mesh Nebulizer, Model NE-U22V/NE-22VAC; Distributed by: Omron Healthcare, Inc., 300 Lakeview Parkway, Vernon Hills, IL 60061
Brand
Omron Healthcare, Inc.
Lot Codes / Batch Numbers
Bottle lots 43A, 53A, 63A, 73A, 83A, 93A, X3A, Y3A and Z3A, a component of Nebulizer model NE-U22 serial numbers 3400001A and higher, 3500001A and higher, 3600001A and higher, 3700001A and higher, 3800001A and higher, 3900001A and higher, 3X00001A and higher, 3Y00001A and higher
Products Sold
Bottle lots 43A, 53A, 63A, 73A, 83A, 93A, X3A, Y3A and Z3A, a component of Nebulizer model NE-U22 serial numbers 3400001A and higher, 3500001A and higher, 3600001A and higher, 3700001A and higher, 3800001A and higher, 3900001A and higher, 3X00001A and higher, 3Y00001A and higher, and 3Z00001A through 3Z00696A. Medication bottles with either a blue dot or a blue O-ring were manufactured after corrections were made and are not subject to the recall.
Omron Healthcare, Inc. is recalling Medication Bottle (U22-3), a component of the MicroAir Vibrating Mesh Nebulizer, Model NE-U22V/NE-22 due to A potential failure of the vibrating mechanism of the medication bottle which causes a failure to transmit vibration and results in no nebulization.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A potential failure of the vibrating mechanism of the medication bottle which causes a failure to transmit vibration and results in no nebulization.
Recommended Action
Per FDA guidance
Omron sent 'Removal Notices' dated 11/2/04 to all of their direct accounts receiving the nebulizers during the affected time frame. The accounts were informed of the potential failure of the vibrating mechanism, and listed the serial numbers of the nebulizers that may contain the affected medication bottles. Medication bottles with either a blue dot near the bottle lever or a blue O-ring around the body of the bottle were manufactured after corrections were made and are not subject to the recall. Affected product should be returned to Omron for replacement. Any questions were directed to Customer Service at 800-231-4030.
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