CDI OneView Monitoring System (Terumo) – Display Value Issue (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
Brand
Terumo Cardiovascular Systems Corporation
Lot Codes / Batch Numbers
UDI/DI 00886799001882, Serial Number range: H0050095-H0050110, H0050112-H0050116, H0050118-H0050124, H0050126, H0050131-H0050134, H0050136, H0050140-H0050142
Products Sold
UDI/DI 00886799001882, Serial Number range: H0050095-H0050110, H0050112-H0050116, H0050118-H0050124, H0050126, H0050131-H0050134, H0050136, H0050140-H0050142
Terumo Cardiovascular Systems Corporation is recalling Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754 due to During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavaila. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Terumo Cardiovascular issued an URGENT MEDICAL DEVICE REMOVAL notice to its consignees on 03/03/2025 via email. The notice explained the reason for the removal, potential hazard, and requested the following: 1. Review this Medical Device Correction and assure that all users have received notice of this issue. 2. Confirm receipt of this communication by completing and returning the attached Customer Response Form as indicated on the form. 3. Terumo CVS will contact users to discuss removal and correction activities. Note: Terumo CVS recommends that users continue using CDI OneView System H/S Probes while waiting for this removal
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 noticeDistribution
As reported by FDA
FL, IL, MI, NV, NY, TX
Page updated: Jan 10, 2026