CLASS II ONGOING Device recall · Reported 9 Apr 2025 · FDA Enforcement Report
Terumo CDI OneView Monitoring System Hematocrit / Oxygen recalled
Terumo Cardiovascular Systems is recalling Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, distributed in Florida, Illinois, Michigan, Nevada, New York, Texas. The recall was initiated on 3 Mar 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1492-2025
- FDA event ID
- 96331
- Recalling firm
- Terumo Cardiovascular Systems, Ann Arbor, MI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Mar 2025
- FDA classified
- 31 Mar 2025
- Reported
- 9 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 3 Mar 2025 | Recall initiated by company | |
| 31 Mar 2025 | Classified by FDA | +28 days |
| 9 Apr 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavailable data. In these cases, a yellow low-limit alarm will also be triggered to the user, due to the dashed-out value.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
Where it was distributed
US: IL, TX, NY, MI, FL, NV, and Australia, New Zealand
Questions about this recall
Why was it recalled?
During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavailable data. In these cases, a yellow low-limit alarm will also be triggered to the user, due to the dashed-out value.
Which lots are affected?
UDI/DI 00886799001882, Serial Number range: H0050095-H0050110, H0050112-H0050116, H0050118-H0050124, H0050126, H0050131-H0050134, H0050136, H0050140-H0050142
Where was it sold?
US: IL, TX, NY, MI, FL, NV, and Australia, New Zealand
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Terumo Cardiovascular Systems
All 222| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | CDI OneView System BPM Probe recalled by Terumo Cardiovascular Systems | Terumo Cardiovascular Systems | Labeling Errors | Nationwide |
| Device | CLASS II | Cardiovascular Procedure Kits that include High Crack Check recalled | Terumo Cardiovascular Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Capiox RX15 Hollow Fiber Oxygenator recalled | Terumo Cardiovascular Systems | Packaging Defects | Nationwide |
| Device | CLASS II | Capiox FX25 Hollow Fiber Oxygenator recalled | Terumo Cardiovascular Systems | Packaging Defects | Nationwide |
| Device | CLASS II | Capiox NX19 Hollow Fiber Oxygenator recalled | Terumo Cardiovascular Systems | Packaging Defects | Nationwide |
Other Patient Monitors recalls
All 1,014| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | nGenuity Patient Monitor with Capnography recalled | Criticare Technologies | Device Malfunction | Nationwide |
| Device | CLASS I | Bravo CF capsule delivery device, Product Number FGS recalled | Given Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |