Browse Device Recalls
223 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 223 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 223 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 26, 2013 | Terumo¿ Advanced Perfusion System 1: 220/240V AC, Advanced Perfusion System ... | The operators manual does not fully describe the sequence of expected events that will occur when... | Class II | Terumo Cardiovascular Systems Corporation |
| Jul 26, 2013 | 220/240V AC, Advanced Perfusion System 1 Product Usage: The Terumo¿ Advan... | TCVS is taking action to update the Operators Manual with the specific instructions to respond to... | Class II | Terumo Cardiovascular Systems Corporation |
| Jul 26, 2013 | Terumo¿ Advanced Perfusion System 1 (APS1, System 1) Description: 220/240V A... | Terumo Cardiovascular Systems (TCVS) has become aware that an Advanced Perfusion System 1 (APS1)... | Class II | Terumo Cardiovascular Systems Corporation |
| Jul 26, 2013 | Terumo Pall AL6X Arterial Blood Line Filter, labeled in part Terumo Cardiovas... | Medical device used in cardiovascular procedures is defective. | Class II | Terumo Cardiovascular Systems Corporation |
| Jul 26, 2013 | 100/120V AC, Advanced Perfusion System 1 Product Usage: The Terumo¿ Advan... | TCVS is taking action to update the Operators Manual with the specific instructions to respond to... | Class II | Terumo Cardiovascular Systems Corporation |
| Jun 4, 2013 | Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Over... | Over-Pressure Safety Valves not cleared with an indication for use on the arterial side of the ex... | Class II | Terumo Cardiovascular Systems Corporation |
| May 30, 2013 | Sarns " TCM II Temperature Control Module The Sarns" TCM II Temperature Co... | Internal testing found certain Sarns" TCM II systems were released with incorrectly assembled hea... | Class II | Terumo Cardiovascular Systems Corporation |
| Feb 27, 2013 | CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood para... | Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software... | Class II | Terumo Cardiovascular Systems Corporation |
| Feb 27, 2013 | CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood para... | Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software... | Class II | Terumo Cardiovascular Systems Corporation |
| Feb 27, 2013 | CDI Blood Parameter Monitoring System 500 with Venous blood parameter module.... | Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software... | Class II | Terumo Cardiovascular Systems Corporation |
| Feb 27, 2013 | CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modul... | Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software... | Class II | Terumo Cardiovascular Systems Corporation |
| Feb 27, 2013 | CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modul... | Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software... | Class II | Terumo Cardiovascular Systems Corporation |
| Jan 7, 2013 | Sarns flexible arterial cannula, 6.7 mm (20Fr) OD with 3/8 in. connector, sut... | 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, 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 |
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.