| CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - recall (Z-2018-2025) | Terumo Cardiovascular Systems Corporation | 2025-06-24 |
| Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number recall (Z-1492-2025) | Terumo Cardiovascular Systems Corporation | 2025-03-31 |
| Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: recall (Z-1401-2024) | Terumo Cardiovascular Systems Corporation | 2024-03-29 |
| CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30 recall (Z-1345-2023) | Terumo Cardiovascular Systems Corporation | 2023-04-05 |
| CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE recall (Z-1346-2023) | Terumo Cardiovascular Systems Corporation | 2023-04-05 |
| CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC recall (Z-1347-2023) | Terumo Cardiovascular Systems Corporation | 2023-04-05 |
| Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX2 Temperature Ma recall (Z-1416-2018) | Terumo Cardiovascular Systems Corporation | 2018-04-18 |
| Sarns TCM, Catalog No. 15747 The Sarns TCM is indicated for controlling and monitoring pat recall (Z-1417-2018) | Terumo Cardiovascular Systems Corporation | 2018-04-18 |
| Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI 00886799000014 recall (Z-1418-2018) | Terumo Cardiovascular Systems Corporation | 2018-04-18 |
| Terumo Advanced Perfusion System 1-Level Sensor II Pads, Product Usage: Ultrasonic couplan recall (Z-1458-2017) | Terumo Cardiovascular Systems Corporation | 2017-03-14 |
| Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads Product Usage: Level sensor pa recall (Z-1459-2017) | Terumo Cardiovascular Systems Corporation | 2017-03-14 |
| Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment recall (Z-1232-2017) | Terumo Cardiovascular Systems Corporation | 2017-02-22 |
| The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The de recall (Z-1235-2017) | Terumo Cardiovascular Systems Corporation | 2017-02-22 |
| Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless recall (Z-1201-2017) | Terumo Cardiovascular Systems Corporation | 2017-02-14 |
| HX2" Temperature Management Systems; The Terumo HX2" Temperature Management System provide recall (Z-2207-2016) | Terumo Cardiovascular Systems Corporation | 2016-07-14 |
| Sarns TCM; The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature recall (Z-2208-2016) | Terumo Cardiovascular Systems Corporation | 2016-07-14 |
| Sarns TCM II; The Sarns Temperature Control and Monitor unit (TCM) II (system) is a source recall (Z-2209-2016) | Terumo Cardiovascular Systems Corporation | 2016-07-14 |
| Preamendments device-Sarns Dual Cooler-Heater. The Sarns Dual Cooler-Heater is a self-cont recall (Z-2210-2016) | Terumo Cardiovascular Systems Corporation | 2016-07-14 |
| CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas monitor recall (Z-1250-2016) | Terumo Cardiovascular Systems Corporation | 2016-03-25 |
| CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the recall (Z-2742-2015) | Terumo Cardiovascular Systems Corporation | 2015-09-09 |
| 100/120V AC, Advanced Perfusion System Platform (APS) The Terumo Advanced Perfusion System recall (Z-1687-2015) | Terumo Cardiovascular Systems Corporation | 2015-05-28 |
| Base for Terumo Advanced Perfusion System 1, 220/240V The Terumo Advanced Perfusion System recall (Z-1688-2015) | Terumo Cardiovascular Systems Corporation | 2015-05-28 |
| Terumo HX2 Temperature Management System provides temperature control of two independent w recall (Z-1116-2015) | Terumo Cardiovascular Systems Corporation | 2015-02-13 |
| Sarns D4 Aortic Arch Cannulae 6.0mm, 7mm & 8mm angled and straight tip with or without sid recall (Z-2094-2014) | Terumo Cardiovascular Systems Corporation | 2014-07-23 |
| Sarns Flexible Aortic Arch Cannula 8.0mm with luer, 3/8" connector Product Usage: The Aort recall (Z-2095-2014) | Terumo Cardiovascular Systems Corporation | 2014-07-23 |
| Sarns Malleable Dual-stage Venous Return Cannulae 28/38, 32/40 & 34/46 Fr with 1/2" connec recall (Z-2096-2014) | Terumo Cardiovascular Systems Corporation | 2014-07-23 |
| Sarns Malleable Venous Return Cannulae 24, 28, 30, 32, 34, 36 & 40 Fr single stage with 3/ recall (Z-2097-2014) | Terumo Cardiovascular Systems Corporation | 2014-07-23 |
| Sarns Soft-arc Aortic Cannula 8.0mm curved tip, suture flange, 3/8" flare Product Usage: T recall (Z-2098-2014) | Terumo Cardiovascular Systems Corporation | 2014-07-23 |
| Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer & Xcoating, Pr recall (Z-2099-2014) | Terumo Cardiovascular Systems Corporation | 2014-07-23 |
| Sarns Two-stage Venous Return Cannulae 32/40 & 36/51 Fr with 1/2" & 3/8" flare or connecto recall (Z-2100-2014) | Terumo Cardiovascular Systems Corporation | 2014-07-23 |
| Sarns Venoatrial Cannulae 36/46 Fr with 1/2" flare or connector Product Usage: The Aortic recall (Z-2101-2014) | Terumo Cardiovascular Systems Corporation | 2014-07-23 |
| Terumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & 36/51 Fr with recall (Z-2102-2014) | Terumo Cardiovascular Systems Corporation | 2014-07-23 |
| Terumo TenderFlow Pediatric Venous Cannulae, 8, 10, 12, 14, 16, 18, 20, 22 & 24 Fr angled recall (Z-2103-2014) | Terumo Cardiovascular Systems Corporation | 2014-07-23 |
| Terumo Three-stage Venous Return Cannulae 28 Fr with 3/8" flare, 30 Fr with 3/8" connector recall (Z-2104-2014) | Terumo Cardiovascular Systems Corporation | 2014-07-23 |
| Sarns Soft-Flow Aortic Cannulae 6.0mm, 7mm & 8mm angled and straight tip, suture bulb with recall (Z-2105-2014) | Terumo Cardiovascular Systems Corporation | 2014-07-23 |
| CPB Catheter Kit Product Usage: Venous Return Cannula is indicated for venous drainage dur recall (Z-2106-2014) | Terumo Cardiovascular Systems Corporation | 2014-07-23 |
| Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use devic recall (Z-2028-2014) | Terumo Cardiovascular Systems Corporation | 2014-07-11 |
| Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device recall (Z-2029-2014) | Terumo Cardiovascular Systems Corporation | 2014-07-11 |
| Cardiovascular Procedure Kit containing Disposable Centrifugal Pumphead with or without X- recall (Z-2030-2014) | Terumo Cardiovascular Systems Corporation | 2014-07-11 |
| Terumo Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System Platform (APS) recall (Z-2018-2014) | Terumo Cardiovascular Systems Corporation | 2014-07-08 |
| Terumo Advanced Perfusion System 1 220/240V AC, Advanced Perfusion System Platform (APS) recall (Z-2019-2014) | Terumo Cardiovascular Systems Corporation | 2014-07-08 |
| CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 145891, 500AVHCT; recall (Z-1634-2014) | Terumo Cardiovascular Systems Corporation | 2014-05-19 |
| Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connector, 14.5" (37 recall (Z-1218-2014) | Terumo Cardiovascular Systems Corporation | 2014-03-19 |
| Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connector, 14.5" (37 recall (Z-1219-2014) | Terumo Cardiovascular Systems Corporation | 2014-03-19 |
| Sarns Malleable Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" connector, 15" (38 c recall (Z-1220-2014) | Terumo Cardiovascular Systems Corporation | 2014-03-19 |
| Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" connector, 15" (38 c recall (Z-1221-2014) | Terumo Cardiovascular Systems Corporation | 2014-03-19 |
| Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" connector, 15" (38 c recall (Z-1222-2014) | Terumo Cardiovascular Systems Corporation | 2014-03-19 |
| Sarns Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" flare The Sarns Malleable Dual recall (Z-1223-2014) | Terumo Cardiovascular Systems Corporation | 2014-03-19 |
| Sarns Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" flare The Sarns Malleable Dual recall (Z-1224-2014) | Terumo Cardiovascular Systems Corporation | 2014-03-19 |
| VirtuoSaph Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx Onl recall (Z-1069-2014) | Terumo Cardiovascular Systems Corporation | 2014-02-21 |
| Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safe recall (Z-0603-2014) | Terumo Cardiovascular Systems Corporation | 2013-12-27 |
| Vascutek Gelsoft Vascular Graft (peripheral) Labeling reads in part, "***Gelsoft Gelatin I recall (Z-0336-2014) | Terumo Cardiovascular Systems Corporation | 2013-11-18 |
| Sarns" Soft-Flow Aortic Cannula without Suture Flange, angled tip, wire-reinforced with lu recall (Z-0193-2014) | Terumo Cardiovascular Systems Corporation | 2013-11-08 |
| Sarns" Soft-Flow Aortic Cannula without Suture Flange, straight tip, wire-reinforced with recall (Z-0194-2014) | Terumo Cardiovascular Systems Corporation | 2013-11-08 |
| Sarns" Soft-Flow Aortic Cannula without Suture Flange, straight tip, wire-reinforced with recall (Z-0195-2014) | Terumo Cardiovascular Systems Corporation | 2013-11-08 |
| Sarns" Venous Return Cannulae, 20 Fr with 1/4" flare, 14.5" (37 cm) long. Indicated for ve recall (Z-0196-2014) | Terumo Cardiovascular Systems Corporation | 2013-11-08 |
| Terumo Pall AL6X Arterial Blood Line Filter, labeled in part Terumo Cardiovascular Systems recall (Z-2261-2013) | Terumo Cardiovascular Systems Corporation | 2013-09-20 |
| 100/120V AC, Advanced Perfusion System 1 Product Usage: The Terumo Advanced Perfusion Syst recall (Z-1977-2013) | Terumo Cardiovascular Systems Corporation | 2013-08-15 |
| 220/240V AC, Advanced Perfusion System 1 Product Usage: The Terumo Advanced Perfusion Syst recall (Z-1978-2013) | Terumo Cardiovascular Systems Corporation | 2013-08-15 |
| Terumo Advanced Perfusion System 1: 100/120V AC, Advanced Perfusion System 1 The Terumo Ad recall (Z-1968-2013) | Terumo Cardiovascular Systems Corporation | 2013-08-14 |
| Terumo Advanced Perfusion System 1: 220/240V AC, Advanced Perfusion System 1 The Terumo Ad recall (Z-1969-2013) | Terumo Cardiovascular Systems Corporation | 2013-08-14 |
| Terumo Advanced Perfusion System 1 (APS1, System 1) 100/120V AC Product Usage: The Terumo recall (Z-1973-2013) | Terumo Cardiovascular Systems Corporation | 2013-08-14 |
| Terumo Advanced Perfusion System 1 (APS1, System 1) Description: 220/240V AC Product Usage recall (Z-1974-2013) | Terumo Cardiovascular Systems Corporation | 2013-08-14 |
| CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules recall (Z-1730-2013) | Terumo Cardiovascular Systems Corporation | 2013-07-13 |
| CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and Hemato recall (Z-1731-2013) | Terumo Cardiovascular Systems Corporation | 2013-07-13 |
| CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules recall (Z-1732-2013) | Terumo Cardiovascular Systems Corporation | 2013-07-13 |
| CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module. Intended f recall (Z-1733-2013) | Terumo Cardiovascular Systems Corporation | 2013-07-13 |
| CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended for recall (Z-1734-2013) | Terumo Cardiovascular Systems Corporation | 2013-07-13 |
| Sarns " TCM II Temperature Control Module The Sarns" TCM II Temperature Control Module is recall (Z-1569-2013) | Terumo Cardiovascular Systems Corporation | 2013-06-21 |
| Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen satur recall (Z-0802-2013) | Terumo Cardiovascular Systems Corporation | 2013-02-12 |
| Sarns flexible arterial cannula, 6.7 mm (20Fr) OD with 3/8 in. connector, suture ring, 9.5 recall (Z-0666-2013) | Terumo Cardiovascular Systems Corporation | 2013-01-11 |
| Sarns flexible arterial cannula, 7.3 mm (22 Fr) OD with 3/8in connector, suture ring, 9.5i recall (Z-0667-2013) | Terumo Cardiovascular Systems Corporation | 2013-01-11 |
| Sarns flexible arterial cannula, 8.0 mm (24 Fr) with 3/8in connector, suture ring, 9.5in ( recall (Z-0668-2013) | Terumo Cardiovascular Systems Corporation | 2013-01-11 |
| Sarns high-flow aortic arch cannula, 5.2 mm (16 Fr) OD with 3/8in connector, 7.5in (19 cm) recall (Z-0669-2013) | Terumo Cardiovascular Systems Corporation | 2013-01-11 |
| Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) recall (Z-0670-2013) | Terumo Cardiovascular Systems Corporation | 2013-01-11 |
| Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) recall (Z-0671-2013) | Terumo Cardiovascular Systems Corporation | 2013-01-11 |
| 24 Fr 8mm Sft Flow Str Wire W/L The Sarns Aortic Cannula is indicated for use in perfusion recall (Z-0456-2013) | Terumo Cardiovascular Systems Corporation | 2012-12-03 |
| 24 Fr 8mm Sft Flow Straight Wir The Sarns Aortic Cannula is indicated for use in perfusion recall (Z-0457-2013) | Terumo Cardiovascular Systems Corporation | 2012-12-03 |
| 24 Fr 8mm Sft Flow Straight The Sarns Aortic Cannula is indicated for use in perfusion of recall (Z-0458-2013) | Terumo Cardiovascular Systems Corporation | 2012-12-03 |
| 18 Fr 6mm Sft Flow Angled Wire The Sarns Aortic Cannula is indicated for use in perfusion recall (Z-0459-2013) | Terumo Cardiovascular Systems Corporation | 2012-12-03 |
| 18 Fr 6mm Sft Flow Ang Wire W/L The Sarns Aortic Cannula is indicated for use in perfusion recall (Z-0460-2013) | Terumo Cardiovascular Systems Corporation | 2012-12-03 |
| 24 Fr 8mm Soft Flow Ang Wire W/L The Sarns Aortic Cannula is indicated for use in perfusio recall (Z-0461-2013) | Terumo Cardiovascular Systems Corporation | 2012-12-03 |
| 24 Fr 8mm Soft Flow Ang W/L The Sarns Aortic Cannula is indicated for use in perfusion of recall (Z-0462-2013) | Terumo Cardiovascular Systems Corporation | 2012-12-03 |
| 100/120V AC, Advanced Perfusion System Platform (APS) The Terumo Advanced Perfusion System recall (Z-0435-2013) | Terumo Cardiovascular Systems Corporation | 2012-11-27 |
| 220/240V AC, Advanced Perfusion System Platform (APS) The Terumo Advanced Perfusion System recall (Z-0436-2013) | Terumo Cardiovascular Systems Corporation | 2012-11-27 |
| HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a selfcontained, recall (Z-0278-2013) | Terumo Cardiovascular Systems Corporation | 2012-11-13 |
| Tested AC Control BD, 120V, X2 The Terumo HX2 Temperature Management System is a selfconta recall (Z-0279-2013) | Terumo Cardiovascular Systems Corporation | 2012-11-13 |
| Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns" Modular Perfus recall (Z-0280-2013) | Terumo Cardiovascular Systems Corporation | 2012-11-13 |
| Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns" Modular Perfus recall (Z-0281-2013) | Terumo Cardiovascular Systems Corporation | 2012-11-13 |
| Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The Sarns" Modular P recall (Z-0282-2013) | Terumo Cardiovascular Systems Corporation | 2012-11-13 |
| Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns" Modular P recall (Z-0283-2013) | Terumo Cardiovascular Systems Corporation | 2012-11-13 |
| Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns" Modular Perfus recall (Z-0284-2013) | Terumo Cardiovascular Systems Corporation | 2012-11-13 |
| Perfusion System 8000, base 5 pump, 100V safety monitor included The Sarns" Modular Perfus recall (Z-0285-2013) | Terumo Cardiovascular Systems Corporation | 2012-11-13 |
| Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns Modular Perfusi recall (Z-0126-2013) | Terumo Cardiovascular Systems Corporation | 2012-10-24 |
| Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns Modular Perfusi recall (Z-0127-2013) | Terumo Cardiovascular Systems Corporation | 2012-10-24 |
| Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The Sarns Modular Pe recall (Z-0128-2013) | Terumo Cardiovascular Systems Corporation | 2012-10-24 |
| Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns Modular Pe recall (Z-0129-2013) | Terumo Cardiovascular Systems Corporation | 2012-10-24 |
| Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns Modular Perfusi recall (Z-0130-2013) | Terumo Cardiovascular Systems Corporation | 2012-10-24 |
| Perfusion System 8000, base 5 pump, 100V safety monitor included The Sarns Modular Perfusi recall (Z-0131-2013) | Terumo Cardiovascular Systems Corporation | 2012-10-24 |
| Terumo Backplate Replacement CXFVR 1500 Holder The Flexible venous Reservoir is mounted on recall (Z-0071-2013) | Terumo Cardiovascular Systems Corporation | 2012-10-16 |