FDA Medical devices recall ·
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe recall
- Recall number
- Z-1492-2025
- Date
- (initiated March 3, 2025)
- Company / brand
- Terumo Cardiovascular Systems Corporation
6200 Jackson Rd, Ann Arbor, MI, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 37 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 00886799001882, Serial Number range: H0050095-H0050110, H0050112-H0050116, H0050118-H0050124, H0050126, H0050131-H0050134, H0050136, H0050140-H0050142
Distribution
US: IL, TX, NY, MI, FL, NV, and Australia, New Zealand
States: Florida Illinois Michigan Nevada New York Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1492-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.