Drugs & medicalClass II

Terumo Cardiovascular Systems Corporation recalls CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial…

Due to an error in assembly of the thermistor within some units, the affected probes will experience inaccuracy in measured shunt sensor temperature. Additionally, following changes in patient temperature without an in…

Read the official notice →
Date
2025-07-02
Country
United States
Brand
Terumo Cardiovascular Systems
Product
CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit
Classification
Class II
Units
US Nationwide distribution in the states of California, Delaware, Hawaii,…
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Terumo Cardiovascular Systems recalls

  1. 2025-04-09
  2. US
    Drugs & medicalClass II

    Terumo Cardiovascular Systems Corporation recalls Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754

    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…

    FDA · DeviceTerumo Cardiovascular Systems CorporationUS: IL, TX, NY, MI, FL, NV, and Australia, New ZealandOfficial notice →
  3. 2024-04-10
  4. US
    Drugs & medicalClass II

    Terumo Cardiovascular Systems Corporation recalls Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974 65246 66312…

    Pressure relief valve included in certain lots of cardiovascular procedure kits was reportedly opening at approximately 200-300mmHg versus 400mmHg, potential myocardial tissue damage potentially requiring surgical or…

    FDA · DeviceTerumo Cardiovascular Systems Corporationworldwide distribution - US Nationwide and the countries of Canada, Chile,…Official notice →
  5. 2023-04-12
  6. US
    Drugs & medicalClass II

    Terumo Cardiovascular Systems Corporation recalls CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE

    Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where the arterial thermistor is improperly…

    FDA · DeviceTerumo Cardiovascular Systems CorporationUS Nationwide. Belgium, Canada, Costa Rica, Thailand.Official notice →
  7. 2022-04-27
  8. US
    Drugs & medicalClass II

    Terumo Cardiovascular Systems Corp recalls Cardiovascular Procedure Kit catalog # 76645 & 73806

    Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping.

    FDA · DeviceTerumo Cardiovascular Systems CorpUS Nationwide distribution in the states of CA and IN.Official notice →
All 5 Terumo Cardiovascular Systems recalls →

Other drugs & medical recalls in the United States

  1. 2025-07-02
  2. US
    Drugs & medicalClass II

    Jewel Precision Sheet Metal & Machining Co, Inc. recalls Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.

    The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.

    FDA · DeviceJewel Precision Sheet Metal & Machining Co, Inc.US Nationwide distribution in the states of IN, NY, PA.Official notice →
  3. US
    Drugs & medicalClass II

    Limacorporate S.p.A recalls PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile

    There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.

    FDA · DeviceLimacorporate S.p.AWorldwide - US Nationwide distribution in the states of VA, FL, SC, MS, NY, TX…Official notice →
  4. US
    Drugs & medicalClass II

    Becton Dickinson & Co. recalls BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to…

    BD has received additional complaints of intermittent false resistance results for PZA during susceptibility testing of Mycobacterium tuberculosis isolates.

    FDA · DeviceBecton Dickinson & Co.Worldwide distribution - US Nationwide and the countries of AR, AU, BD, BE,…Official notice →
  5. US
    Drugs & medicalClass II

    CareFusion 303, Inc. recalls Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation 4000 Main…

    During automated dispensing cabinet upgrade/installation/reimaging, component manager was left in installed mode, and if a Microsoft patch is then installed this may lead to an error preventing user access to the…

    FDA · DeviceCareFusion 303, Inc.Worldwide - US Nationwide distribution including in the states of PR, DE, GU,…Official notice →
  6. US
    Drugs & medicalClass II

    Insulet Corporation recalls Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version: all Product…

    Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a comma is not recognized as a decimal separator and the user cannot enter a decimal separator in any manual entry screen if…

    FDA · DeviceInsulet CorporationUS market only- Although there are 122823 downloads of the application, our…Official notice →
  7. US
    Drugs & medicalClass II

    RECORDATI RARE DISEASES INC. recalls Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets…

    Out of specification stability test result for the Caphosol B solution from process validation lots

    FDA · DeviceRECORDATI RARE DISEASES INC.Worldwide - US Nationwide distribution in the states of GA, OH, TN, TX, VA and…Official notice →
See all drugs & medical recalls →