Browse Device Recalls
204 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 204 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 204 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 7, 2013 | Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, ... | Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain... | Class II | Terumo Cardiovascular Systems Corporation |
| Jan 7, 2013 | Sarns flexible arterial cannula, 7.3 mm (22 Fr) OD with 3/8in connector, sutu... | Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain... | Class II | Terumo Cardiovascular Systems Corporation |
| Jan 7, 2013 | Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, ... | Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain... | Class II | Terumo Cardiovascular Systems Corporation |
| Jan 7, 2013 | Sarns flexible arterial cannula, 8.0 mm (24 Fr) with 3/8in connector, suture ... | Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain... | Class II | Terumo Cardiovascular Systems Corporation |
| Jan 7, 2013 | Sarns high-flow aortic arch cannula, 5.2 mm (16 Fr) OD with 3/8in connector, ... | Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain... | Class II | Terumo Cardiovascular Systems Corporation |
| Nov 21, 2012 | 18 Fr 6mm Sft Flow Angled Wire The Sarns Aortic Cannula is indicated for u... | The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic... | Class II | Terumo Cardiovascular Systems Corporation |
| Nov 21, 2012 | 24 Fr 8mm Soft Flow Ang Wire W/L The Sarns Aortic Cannula is indicated for... | The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic... | Class II | Terumo Cardiovascular Systems Corporation |
| Nov 21, 2012 | 18 Fr 6mm Sft Flow Ang Wire W/L The Sarns Aortic Cannula is indicated for ... | The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic... | Class II | Terumo Cardiovascular Systems Corporation |
| Nov 21, 2012 | 24 Fr 8mm Sft Flow Straight The Sarns Aortic Cannula is indicated for use ... | The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic... | Class II | Terumo Cardiovascular Systems Corporation |
| Nov 21, 2012 | 24 Fr 8mm Sft Flow Str Wire W/L The Sarns Aortic Cannula is indicated for ... | The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic... | Class II | Terumo Cardiovascular Systems Corporation |
| Nov 21, 2012 | 24 Fr 8mm Sft Flow Straight Wir The Sarns Aortic Cannula is indicated for ... | The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic... | Class II | Terumo Cardiovascular Systems Corporation |
| Nov 21, 2012 | 24 Fr 8mm Soft Flow Ang W/L The Sarns Aortic Cannula is indicated for use ... | The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic... | Class II | Terumo Cardiovascular Systems Corporation |
| Nov 14, 2012 | 100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced... | Terumo Cardiovascular System (TCVS) has received reports of a situation where users experienced a... | Class II | Terumo Cardiovascular Systems Corporation |
| Nov 14, 2012 | 220/240V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced... | Terumo Cardiovascular System (TCVS) has received reports of a situation where users experienced ... | Class II | Terumo Cardiovascular Systems Corporation |
| Oct 16, 2012 | Tested AC Control BD, 120V, X2 The Terumo HX2 Temperature Management Syste... | Based on a retrospective review of quality data, AC Control boards used in the manufacture of the... | Class II | Terumo Cardiovascular Systems Corporation |
| Oct 16, 2012 | HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a... | Based on a retrospective review of quality data, AC Control boards used in the manufacture of the... | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 25, 2012 | Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns... | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various ma... | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 25, 2012 | Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The ... | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various ma... | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 25, 2012 | Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns... | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various ma... | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 25, 2012 | Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The ... | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various ma... | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 25, 2012 | Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The ... | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various ma... | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 25, 2012 | Perfusion System 8000, base 5 pump, 100V safety monitor included The Sarns... | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various ma... | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 25, 2012 | Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns... | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various ma... | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 25, 2012 | Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns... | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various ma... | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 25, 2012 | Perfusion System 8000, base 5 pump, 100V safety monitor included The Sarns... | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various ma... | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 25, 2012 | Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns... | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various ma... | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 25, 2012 | Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The ... | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various ma... | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 25, 2012 | Battery, 100/115V (Includes charger and connecting cable) The Sarns" Centr... | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2004 of various m... | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 25, 2012 | Battery, 220V (Includes charger and connecting cable) The Sarns" Centrifug... | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2004 of various m... | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 25, 2012 | Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns... | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various ma... | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 24, 2012 | Sarns Centrifugal System Control module, 220/240V The Sarns Centrifugal Sy... | Terumo Cardiovascular Systems (Terumo CVS) received one report of loss of power to the control m... | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 24, 2012 | Sarns Centrifugal System Control module, 100/115V The Sarns Centrifugal Sy... | Terumo Cardiovascular Systems (Terumo CVS) received one report of loss of power to the control m... | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 24, 2012 | Sarns Centrifugal System Control module System 9000 The Sarns Centrifugal ... | Terumo Cardiovascular Systems (Terumo CVS) received one report of loss of power to the control mo... | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 20, 2012 | Terumo Advanced Perfusion System 1 Flow Module indicated for use in extrac... | Terumo Cardiovascular Systems (CVS) received one report of a flow module for the Terumo Advanced ... | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 10, 2012 | Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD Product Usage: The Te... | Terumo Cardiovascular Systems (CVS) received two reports of the false back flow alarms for the Te... | Class II | Terumo Cardiovascular Systems Corporation |
| Jul 26, 2012 | Serial interface module RS-485 Product Usage: The System 1 provides perfu... | Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data tra... | Class II | Terumo Cardiovascular Systems Corporation |
| Jul 26, 2012 | Interface module for CDl System 100/101 Product Usage: The Interface Modu... | Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data tra... | Class II | Terumo Cardiovascular Systems Corporation |
| Jul 26, 2012 | Interface module for CDl System 500 Product Usage: The Interface Module f... | Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data tra... | Class II | Terumo Cardiovascular Systems Corporation |
| Jul 26, 2012 | System 1 base 100/120V The Terumo Advanced Perfusion System 1 is indicated... | Terumo Cardiovascular Systems sent a Safety Advisory (AA-2010-007-C) on December 2, 2010 (Recall#... | Class II | Terumo Cardiovascular Systems Corporation |
| Jul 26, 2012 | Serial interface module RS-232 Product Usage: The System 1 provides perfu... | Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data tra... | Class II | Terumo Cardiovascular Systems Corporation |
| Jul 26, 2012 | System 1 base 220/240V The Terumo Advanced Perfusion System 1 is indicated... | Terumo Cardiovascular Systems sent a Safety Advisory (AA-2010-007-C) on December 2, 2010 (Recall#... | Class II | Terumo Cardiovascular Systems Corporation |
| Jun 25, 2012 | System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated... | Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump occlusion ... | Class II | Terumo Cardiovascular Systems Corporation |
| Jun 25, 2012 | System 1 Base 220/240V. The Terumo Advanced Perfusion System 1 is indicate... | Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump malfunctio... | Class II | Terumo Cardiovascular Systems Corporation |
| Jun 25, 2012 | System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated... | Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump malfunctio... | Class II | Terumo Cardiovascular Systems Corporation |
| Jun 25, 2012 | System 1 Base 220/240V The Terumo Advanced Perfusion System 1 is indicated... | Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump occlusion ... | Class II | Terumo Cardiovascular Systems Corporation |
| Jun 22, 2012 | System 1 Base 100/120V The Terumo¿ Advanced Perfusion System 1 is indicate... | Terumo Cardiovascular Systems (Terumo CVS) received eight complaints since September 2008 of driv... | Class II | Terumo Cardiovascular Systems Corporation |
| Jun 22, 2012 | System 1 Base, 100/120V The Terumo Advanced Perfusion System 1 is indicat... | Terumo Advanced Perfusion System 1 battery charge is being depleted faster than expected during p... | Class II | Terumo Cardiovascular Systems Corporation |
| Jun 22, 2012 | System 1 Base 220/240V The Terumo¿ Advanced Perfusion System 1 is indicate... | Terumo Cardiovascular Systems (Terumo CVS) received eight complaints since September 2008 of driv... | Class II | Terumo Cardiovascular Systems Corporation |
| Jun 22, 2012 | System 1 Base, 220/240V The Terumo Advanced Perfusion System 1 is indicated... | Terumo Advanced Perfusion System 1 battery charge is being depleted faster than expected during p... | Class II | Terumo Cardiovascular Systems Corporation |
| Jun 22, 2012 | Central Control Module for System 1: System 1 Base, 100/120V The Terumo Ad... | Terumo CVS has received reports of the Central Control Monitor (CCM) for Terumo Advanced Perfusio... | Class II | Terumo Cardiovascular Systems Corporation |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.