Terumo Cardiovascular Systems Corporation: 161 recalls on record

Recalls filed with 1 agency: FDA (161).

First recall on record: June 27, 2012. Most recent: July 2, 2025.

Risk classification: Class II: 160 · Class III: 1

Most recent recalls

DateAgencyProduct
July 2, 2025FDACDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI75…Z-2018-2025
April 10, 2024FDACardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number…Z-1401-2024
December 23, 2020FDA(1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modifi…Z-0565-2021
August 7, 2019FDATerumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19REZ-2101-2019
October 24, 2018FDATerumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188Z-0176-2019
March 22, 2017FDATerumo Advanced Perfusion System 1-Level Sensor II Gel Pads Product Usage: Level sens…Z-1459-2017
July 27, 2016FDASarns TCM; The Sarns Temperature Control and Monitor unit (TCM) is a source of temper…Z-2208-2016
September 16, 2015FDACDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of th…Z-2742-2015
June 3, 2015FDABase for Terumo Advanced Perfusion System 1, 220/240V The Terumo¿ Advanced Perfusion Syst…Z-1688-2015
June 3, 2015FDA100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion Syst…Z-1687-2015
July 30, 2014FDASarns Soft-Flow Aortic Cannulae 6.0mm, 7mm & 8mm angled and straight tip, suture bulb wit…Z-2105-2014
July 30, 2014FDASarns D4 Aortic Arch Cannulae 6.0mm, 7mm & 8mm angled and straight tip with or without si…Z-2094-2014
July 30, 2014FDATerumo Three-stage Venous Return Cannulae 28 Fr with 3/8" flare, 30 Fr with 3/8" connecto…Z-2104-2014
July 30, 2014FDASarns Malleable Venous Return Cannulae 24, 28, 30, 32, 34, 36 & 40 Fr single stage with 3…Z-2097-2014
July 30, 2014FDATerumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & 36/51 Fr wit…Z-2102-2014
July 30, 2014FDATerumo TenderFlow Pediatric Venous Cannulae, 8, 10, 12, 14, 16, 18, 20, 22 & 24 Fr angled…Z-2103-2014
July 30, 2014FDASarns Venoatrial Cannulae 36/46 Fr with 1/2" flare or connector Product Usage: The Ao…Z-2101-2014
July 30, 2014FDACPB Catheter Kit Product Usage: Venous Return Cannula is indicated for venous drainag…Z-2106-2014
July 30, 2014FDASarns Flexible Aortic Arch Cannula 8.0mm with luer, 3/8" connector Product Usage: The…Z-2095-2014
July 30, 2014FDASarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer & Xcoating, …Z-2099-2014
July 30, 2014FDASarns Two-stage Venous Return Cannulae 32/40 & 36/51 Fr with 1/2" & 3/8" flare or connect…Z-2100-2014
July 30, 2014FDASarns Soft-arc Aortic Cannula 8.0mm curved tip, suture flange, 3/8" flare Product Usag…Z-2098-2014
July 30, 2014FDASarns Malleable Dual-stage Venous Return Cannulae 28/38, 32/40 & 34/46 Fr with 1/2" conne…Z-2096-2014
July 23, 2014FDASarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use devi…Z-2028-2014
July 23, 2014FDASarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use devic…Z-2029-2014

Questions about this company

How many recalls does Terumo Cardiovascular Systems Corporation have?
Recalert has 161 U.S. recalls on record for Terumo Cardiovascular Systems Corporation, published between June 27, 2012 and July 2, 2025.
What was the most recent Terumo Cardiovascular Systems Corporation recall?
FDA recall Z-2018-2025, published July 2, 2025: CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit
Which agencies have handled Terumo Cardiovascular Systems Corporation recalls?
Terumo Cardiovascular Systems Corporation appears as the recalling firm in recalls from: FDA (161).

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