FEI 1450057
Omron Healthcare, Inc.
2895 Greenspoint Parkway, Hoffman Est, IL, US
MDR events41All time
Recalls2All time
Registered products17
Establishment typeRepackRepack or Relabel Medical Device
Registered product codes
17 product codes
Recent MDR events
41 on file
- OMRON 3 BLOOD PRESSURENov 10, 2025InjuryMW5178694
- OMRON BLOOD PRESSURE MONITORMay 9, 2023InjuryMW5117434
- OMRON BLOOD PRESSURE MONITORJul 12, 2022MalfunctionMW5110823
- OMRON 3 SERIES UPPER ARM BLOOD PRESSURE MONITORApr 22, 2021Malfunction11705846
- OMRON 3 SERIES UPPER ARM BLOOD PRESSURE MONITORApr 22, 2021Malfunction11705870
- OMRON 3 SERIES UPPER ARM BLOOD PRESSURE MONITORApr 22, 2021Malfunction11705871
- OMRON 3 SERIES UPPER ARM BLOOD PRESSURE MONITORApr 22, 2021Malfunction11705872
- OMRON 3 SERIES UPPER ARM BLOOD PRESSURE MONITORApr 22, 2021Malfunction11705899
- OMRON 3 SERIES UPPER ARM BLOOD PRESSURE MONITORJan 12, 2021Malfunction11154034
- OMRON BLOOD PRESSURE MONITOR, BP786NSep 25, 2019MalfunctionMW5090040
Recalls
2 on file
- TerminatedFeb 4, 2006
Omron is recalling the Omron 3-Way Instant Thermometers due to possible overheating of the probe tip.
View FDA record ↗ - TerminatedJan 5, 2005
A potential failure of the vibrating mechanism of the medication bottle which causes a failure to transmit vibration and results in no nebulization.
View FDA record ↗
Compliance history
Matched by FEI 1450057.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.