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 |
|---|---|---|---|---|
| Feb 6, 2015 | Terumo HX2 Temperature Management System provides temperature control of two ... | Malfunctioning mixing valve and loss of cooling and/or heating capability. System goes to standby... | Class II | Terumo Cardiovascular Systems Corporation |
| Jan 5, 2015 | Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment | Terumo Cardiovascular Systems (Terumo CVS) is voluntarily recalling certain lots of Titan" Stabi... | Class II | Terumo Cardiovascular Systems Corporation |
| Aug 20, 2014 | Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusa... | Terumo Cardiovascular Systems (Terumo CVS) is recalling certain lots of Hercules TM 360 Universal... | Class II | Terumo Cardiovascular Systems Corporation |
| Jun 17, 2014 | Terumo¿ Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System ... | An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accur... | Class II | Terumo Cardiovascular Systems Corporation |
| Jun 17, 2014 | Terumo¿ Advanced Perfusion System 1 220/240V AC, Advanced Perfusion System ... | An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accur... | Class II | Terumo Cardiovascular Systems Corporation |
| May 23, 2014 | Terumo TenderFlow Pediatric Venous Cannulae, 8, 10, 12, 14, 16, 18, 20, 22 & ... | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... | Class II | Terumo Cardiovascular Systems Corporation |
| May 23, 2014 | Sarns Soft-arc Aortic Cannula 8.0mm curved tip, suture flange, 3/8" flare ... | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... | Class II | Terumo Cardiovascular Systems Corporation |
| May 23, 2014 | Sarns Soft-Flow Aortic Cannulae 6.0mm, 7mm & 8mm angled and straight tip, sut... | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... | Class II | Terumo Cardiovascular Systems Corporation |
| May 23, 2014 | Sarns Malleable Venous Return Cannulae 24, 28, 30, 32, 34, 36 & 40 Fr single ... | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... | Class II | Terumo Cardiovascular Systems Corporation |
| May 23, 2014 | CPB Catheter Kit Product Usage: Venous Return Cannula is indicated for ve... | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... | Class II | Terumo Cardiovascular Systems Corporation |
| May 23, 2014 | Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer &... | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... | Class II | Terumo Cardiovascular Systems Corporation |
| May 23, 2014 | Terumo Three-stage Venous Return Cannulae 28 Fr with 3/8" flare, 30 Fr with 3... | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... | Class II | Terumo Cardiovascular Systems Corporation |
| May 23, 2014 | Sarns Venoatrial Cannulae 36/46 Fr with 1/2" flare or connector Product Us... | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... | Class II | Terumo Cardiovascular Systems Corporation |
| May 23, 2014 | Sarns Flexible Aortic Arch Cannula 8.0mm with luer, 3/8" connector Product... | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... | Class II | Terumo Cardiovascular Systems Corporation |
| May 23, 2014 | Terumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & ... | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... | Class II | Terumo Cardiovascular Systems Corporation |
| May 23, 2014 | Sarns Two-stage Venous Return Cannulae 32/40 & 36/51 Fr with 1/2" & 3/8" flar... | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... | Class II | Terumo Cardiovascular Systems Corporation |
| May 23, 2014 | Sarns Malleable Dual-stage Venous Return Cannulae 28/38, 32/40 & 34/46 Fr wit... | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... | Class II | Terumo Cardiovascular Systems Corporation |
| May 23, 2014 | Sarns D4 Aortic Arch Cannulae 6.0mm, 7mm & 8mm angled and straight tip with o... | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... | Class II | Terumo Cardiovascular Systems Corporation |
| May 9, 2014 | CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 1458... | There is a potential for inaccuracies in blood gas readings/measurements. There is a potential ri... | Class II | Terumo Cardiovascular Systems Corporation |
| Apr 14, 2014 | Cardiovascular Procedure Kit containing Disposable Centrifugal Pumphead with... | During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead. | Class II | Terumo Cardiovascular Systems Corporation |
| Apr 14, 2014 | Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, sin... | During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead. | Class II | Terumo Cardiovascular Systems Corporation |
| Apr 14, 2014 | Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, sing... | During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead. | Class II | Terumo Cardiovascular Systems Corporation |
| Mar 3, 2014 | Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" connect... | During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed baske... | Class II | Terumo Cardiovascular Systems Corporation |
| Mar 3, 2014 | Sarns Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" flare The Sarn... | During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed baske... | Class II | Terumo Cardiovascular Systems Corporation |
| Mar 3, 2014 | Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" connect... | During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed baske... | Class II | Terumo Cardiovascular Systems Corporation |
| Mar 3, 2014 | Sarns Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" flare The Sarn... | During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed baske... | Class II | Terumo Cardiovascular Systems Corporation |
| Mar 3, 2014 | Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connect... | During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed baske... | Class II | Terumo Cardiovascular Systems Corporation |
| Mar 3, 2014 | Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connect... | During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed baske... | Class II | Terumo Cardiovascular Systems Corporation |
| Mar 3, 2014 | Sarns Malleable Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" connect... | During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed baske... | Class II | Terumo Cardiovascular Systems Corporation |
| Dec 12, 2013 | VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System, Part number: VSP550, St... | Sterility of medical devices intended for use in surgical procedures may be compromised. | Class II | Terumo Cardiovascular Systems Corporation |
| Oct 23, 2013 | Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, angled tip, wire-rei... | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... | Class II | Terumo Cardiovascular Systems Corporation |
| Oct 23, 2013 | Sarns" Venous Return Cannulae, 20 Fr with 1/4" flare, 14.5" (37 cm) long. ... | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... | Class II | Terumo Cardiovascular Systems Corporation |
| Oct 23, 2013 | Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, straight tip, wire-r... | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... | Class II | Terumo Cardiovascular Systems Corporation |
| Oct 23, 2013 | Vascutek Gelsoft Vascular Graft (peripheral) Labeling reads in part, "***Gel... | Terumo Cardiovascular Systems (Terumo CVS) became aware of a customer complaint that a 15mm x 8mm... | Class II | Terumo Cardiovascular Systems Corporation |
| Oct 23, 2013 | Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, straight tip, wire-r... | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... | Class II | Terumo Cardiovascular Systems Corporation |
| Jul 26, 2013 | Terumo¿ Advanced Perfusion System 1: 100/120V AC, Advanced Perfusion System 1... | 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 | Terumo¿ Advanced Perfusion System 1 (APS1, System 1) 100/120V AC Product ... | Terumo Cardiovascular Systems (TCVS) has become aware that an Advanced Perfusion System 1 (APS1)... | Class II | Terumo Cardiovascular Systems Corporation |
| 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 |
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.