Terumo Cardiovascular Systems Corporation: Medical Device Recall in 2025 - (Recall #: Z-1492-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754

Product Classification:

Class II

Date Initiated: March 3, 2025

Date Posted: April 9, 2025

Recall Number: Z-1492-2025

Event ID: 96331

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.

Status: Ongoing

Product Quantity: 37 units

Code Information:

UDI/DI 00886799001882, Serial Number range: H0050095-H0050110, H0050112-H0050116, H0050118-H0050124, H0050126, H0050131-H0050134, H0050136, H0050140-H0050142

Distribution Pattern:

US: IL, TX, NY, MI, FL, NV, and Australia, New Zealand

Voluntary or Mandated:

Voluntary: Firm initiated