Browse Device Recalls
53 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 53 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 53 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 19, 2017 | Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, S... | The product is labeled with the incorrect expiration date. | Class III | LivaNova USA |
| Sep 28, 2017 | FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Can... | A specific lot of the FlexFlowTM Venous Cannula, 200-200, is being recalled because it is sharpe... | Class II | Sorin Group USA, Inc. |
| Jun 30, 2017 | STOCKERT Heater-Cooler System 3T, 127V/60 Hz | Plastic heat exchanger fibers separating the blood compartment from the water compartment in cert... | Class II | Sorin Group USA, Inc. |
| Jun 30, 2017 | STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 Hz | Plastic heat exchanger fibers separating the blood compartment from the water compartment in cert... | Class II | Sorin Group USA, Inc. |
| Jun 30, 2017 | STOCKERT Heater-Cooler System 3T, 240V/60 Hz | Plastic heat exchanger fibers separating the blood compartment from the water compartment in cert... | Class II | Sorin Group USA, Inc. |
| Jun 30, 2017 | STOCKERT Heater-Cooler System 3T, 208V/60 Hz | Plastic heat exchanger fibers separating the blood compartment from the water compartment in cert... | Class II | Sorin Group USA, Inc. |
| Jun 30, 2017 | STOCKERT Heater-Cooler System 3T, 230 V | Plastic heat exchanger fibers separating the blood compartment from the water compartment in cert... | Class II | Sorin Group USA, Inc. |
| Jun 30, 2017 | STOCKERT Heater-Cooler System 3T, 120V/60 Hz | Plastic heat exchanger fibers separating the blood compartment from the water compartment in cert... | Class II | Sorin Group USA, Inc. |
| Jun 29, 2017 | SORIN GROUP, SMART PERFUSION PACK, SMART VENOUS VACUUM, REF 084118102, STERIL... | Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... | Class II | Sorin Group USA, Inc. |
| Jun 29, 2017 | SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127702, STE... | Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... | Class II | Sorin Group USA, Inc. |
| Jun 29, 2017 | STERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF... | Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... | Class II | Sorin Group USA, Inc. |
| Jun 29, 2017 | SORIN GROUP, SMART PERFUSION PACK, SMART 3/16" PEDS PACK, REF 627263601, STER... | Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... | Class II | Sorin Group USA, Inc. |
| Jun 29, 2017 | SORIN GROUP, SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx O... | Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... | Class II | Sorin Group USA, Inc. |
| Jun 29, 2017 | NON-STERILE SAMPLE, SORIN GROUP, SMART CARDIOPLEGIA, CARDIOPLEGIA PACK, REF 6... | Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... | Class II | Sorin Group USA, Inc. |
| Jun 29, 2017 | NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS, REF 04404... | Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... | Class II | Sorin Group USA, Inc. |
| Jun 29, 2017 | SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERIL... | Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... | Class II | Sorin Group USA, Inc. |
| Jun 29, 2017 | SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, ST... | Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... | Class II | Sorin Group USA, Inc. |
| Jun 29, 2017 | SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx ... | Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... | Class II | Sorin Group USA, Inc. |
| Jun 29, 2017 | SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STER... | Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... | Class II | Sorin Group USA, Inc. |
| Jun 29, 2017 | SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx... | Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... | Class II | Sorin Group USA, Inc. |
| Jun 29, 2017 | SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a)... | Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... | Class II | Sorin Group USA, Inc. |
| Jun 29, 2017 | NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, N... | Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... | Class II | Sorin Group USA, Inc. |
| Jun 29, 2017 | SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 6272550... | Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... | Class II | Sorin Group USA, Inc. |
| Jun 29, 2017 | SORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERI... | Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... | Class II | Sorin Group USA, Inc. |
| Jun 9, 2017 | Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile P... | Identification of excess plastic on the tip of the cannula. | Class II | Sorin Group USA, Inc. |
| Oct 31, 2016 | Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Per... | Sorin Group USA, Inc. announces a voluntary field action for the Perceval Sutureless Heart Valve ... | Class II | Sorin Group USA, Inc. |
| Sep 29, 2016 | The ORCHESTRA Programmer A portable device, equipped with a microprocesso... | Sorin Group USA, Inc. announces a voluntary field action for the ORCHESTRA Programmer and ORCHEST... | Class II | Sorin Group USA, Inc. |
| Sep 29, 2016 | The ORCHESTRA PLUS Programmer A portable device, equipped with a micropro... | Sorin Group USA, Inc. announces a voluntary field action for the ORCHESTRA Programmer and ORCHEST... | Class II | Sorin Group USA, Inc. |
| Aug 25, 2016 | St¿ckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung ... | Sorin/LivaNova is initiating a field correction on the S5 Heart-lung machine because of the poten... | Class II | Sorin Group USA, Inc. |
| Aug 12, 2016 | Coronary Artery Perfusion Cannula with Balloon (part number CP-2200X). The Co... | The tip of the cannula should be bent at either a 45 or 90 degree angle. Samples have been return... | Class II | Sorin Group USA, Inc. |
| Aug 12, 2016 | Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part n... | Sorin Group USA, Inc. announces a voluntary field for the Aortic Arch Cannula and Coronary Artery... | Class II | Sorin Group USA, Inc. |
| Jun 22, 2016 | AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary ... | Sorin Group USA is recalling Aortic Arch Cannulae (part numbers NA-55X7 and NA-55X8) because the ... | Class II | Sorin Group USA, Inc. |
| Jan 25, 2016 | Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Ste... | Sorin Group initiated field correction for the Dual Stage Venous Return Catheter because the inco... | Class II | Sorin Group USA, Inc. |
| Jan 19, 2016 | CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Pe... | The CDI System 500 monitor displays the "H/S DISCONNECT AT CUVETTE" error message when the CDI HI... | Class III | Sorin Group USA, Inc. |
| Jun 15, 2015 | Sorin Stockert Heater-Cooler 3T, 240 V / 60 Hz Temperature control for extr... | Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if p... | Class II | Sorin Group USA, Inc. |
| Jun 15, 2015 | Sorin Stockert Heater-Cooler 3T, 200 V / 50Hz / 60 Hz Temperature control f... | Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if p... | Class II | Sorin Group USA, Inc. |
| Jun 15, 2015 | Sorin Stockert Heater-Cooler 3T, 127 V / 60 Hz Temperature control for extr... | Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if p... | Class II | Sorin Group USA, Inc. |
| Jun 15, 2015 | Sorin Stockert Heater-Cooler 3T, 208 V / 60 Hz Temperature control for extr... | Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if p... | Class II | Sorin Group USA, Inc. |
| Jun 15, 2015 | Sorin Stockert Heater-Cooler 3T, 230 V Temperature control for extracorpore... | Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if p... | Class II | Sorin Group USA, Inc. |
| Jun 15, 2015 | Sorin Stockert Heater-Cooler 3T, 120 V / 60 Hz Temperature control for extr... | Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if p... | Class II | Sorin Group USA, Inc. |
| Aug 1, 2014 | ST¿CKERT HeaterCooler System 3T; Item Number 160281, HeaterCooler 3T, 240... | On August 1, 2014 Sorin Group USA, Inc. informed consignees via letter to review the disinfection... | Class II | Sorin Group USA, Inc. |
| Jul 8, 2013 | Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/... | Sorin Group is recalling certain lots of Edwards Lifesciences Suction Wand Model S099B due to pre... | Class II | Sorin Group USA, Inc. |
| Jan 28, 2013 | Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. ... | Isoline defibrillation leads distributed may have internal insulation breach. | Class II | Sorin Group USA, Inc. |
| Sep 20, 2012 | SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121, 60S... | Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers o... | Class II | Sorin Group USA, Inc. |
| Sep 20, 2012 | SCP Pump Control Panel, Product Code: 60-02-50, Serial Numbers: 60S09131, 60S... | Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers o... | Class II | Sorin Group USA, Inc. |
| Sep 19, 2012 | S5 Mast Roller Pump 85, Item Number: 10-88-60 The Stockert S5/Sorin C5 Sys... | Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers o... | Class II | Sorin Group USA, Inc. |
| Sep 19, 2012 | S5 Mast Roller Pump 150, Item Number: 10-88-00 The Stockert S5/Sorin C5 Sy... | Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers o... | Class II | Sorin Group USA, Inc. |
| Sep 19, 2012 | S5 Single Roller Pump 150, Item Number: 10-80-00 The Stockert S5/Sorin C5 ... | Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers o... | Class II | Sorin Group USA, Inc. |
| Sep 19, 2012 | S5 Double Roller Pump 85, Item Number: 10-85-00 The Stockert S5/Sorin C5 S... | Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers o... | Class II | Sorin Group USA, Inc. |
| Sep 19, 2012 | Sorin C5 Perfusion System, Item number 58-00-00 The Stockert S5/Sorin C5 S... | Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers o... | Class II | Sorin Group USA, Inc. |
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.