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.

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DateProductReasonClassFirm
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.