Browse Device Recalls
52 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 52 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 52 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 5, 2021 | v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model... | Due to a software error, the user may lose functionality of the system or the screen may turn bla... | Class II | Abbott Laboratories Inc. (St Jude Medical) |
| May 5, 2021 | WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012 | Due to a software error, the user may lose functionality of the system or the screen may turn bla... | Class II | Abbott Laboratories Inc. (St Jude Medical) |
| May 5, 2021 | v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Displ... | Due to a software error, the user may lose functionality of the system or the screen may turn bla... | Class II | Abbott Laboratories Inc. (St Jude Medical) |
| Apr 22, 2021 | NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000 | Potential capacitor failure which typically manifests as in inability to provide output on one or... | Class II | Abbott Laboratories Inc. (St Jude Medical) |
| Jan 22, 2020 | Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36... | Past updates to programmers and transmitters may lead some implantable cardioverter defibrillator... | Class II | St Jude Medical, Cardiac Rhythm Management Divi... |
| Jun 20, 2019 | ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs) | Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum... | Class I | St Jude Medical Inc. |
| Jun 20, 2019 | ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: ... | Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum... | Class I | St Jude Medical Inc. |
| Jun 20, 2019 | ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: ... | Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum... | Class I | St Jude Medical Inc. |
| Jun 20, 2019 | ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: ... | Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum... | Class I | St Jude Medical Inc. |
| Jun 20, 2019 | ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs) | Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum... | Class I | St Jude Medical Inc. |
| Jun 20, 2019 | ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs) | Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum... | Class I | St Jude Medical Inc. |
| Apr 5, 2019 | TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 P... | In reported cases, the device log on the TactiSys Quartz Equipment operating on Software Version ... | Class II | Abbott Laboratories Inc. (St Jude Medical) |
| Apr 16, 2018 | Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846;... | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; ... | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195... | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650... | The firm is advising physicians that exposure to sub-freezing temperatures during the supply chai... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | Current, Sterile EO, Model #/ Part #: 1207-30/50020236-001, 60010739-207, 6... | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100... | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | Promote, Sterile EO, Model #/ Part #: 3207-30/60010740-207, 60010740-407; ... | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD326... | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, ... | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623... | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041... | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 1000419... | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: ... | The firm is advising physicians that exposure to sub-freezing temperatures during the supply chai... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | Merlin PCS programmer (Model # 3650), Software (Model # 3330) | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... | Class II | St Jude Medical Inc. |
| Apr 13, 2018 | Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Ca... | Devices inappropriately displayed a low battery indicator determined to be due to memory corruption. | Class II | St Jude Medical, Cardiac Rhythm Management Divi... |
| Aug 28, 2017 | Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: ... | The device may exhibit premature battery depletion. | Class I | St Jude Medical Inc. |
| Aug 28, 2017 | PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) dev... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Aug 28, 2017 | PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker ... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Aug 28, 2017 | Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Nu... | The device may exhibit premature battery depletion. | Class I | St Jude Medical Inc. |
| Aug 28, 2017 | PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (L... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Aug 28, 2017 | Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, P... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Aug 28, 2017 | Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Acce... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Aug 28, 2017 | Assurity MRI Model Numbers: PM1272, PM2272 Implantation of a single-chamber ... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Aug 28, 2017 | Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merli... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Aug 28, 2017 | PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Aug 28, 2017 | Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models E... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Aug 28, 2017 | PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST These low voltage (LV) devic... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Oct 10, 2016 | Fortify VR, Model No. CD1231-40, CD1231-40Q. Fortify ST VR, Model No. CD1241... | St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronizatio... | Class I | St Jude Medical Inc. |
| Oct 10, 2016 | Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quad... | St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronizatio... | Class I | St Jude Medical Inc. |
| Oct 10, 2016 | Unify, Model No. CD3231-40, CD3231-40Q. Unify Quadra, Model No. CD3249-40, C... | St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronizatio... | Class I | St Jude Medical Inc. |
| Mar 31, 2016 | Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411... | St. Jude Medical is recalling the Ellipse ICD (Implantable Cardioverter Defibrillator) due to the... | Class II | St Jude Medical Inc. |
| Nov 3, 2015 | Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, ... | Leads may have been compromised during the manufacturing process, with cuts in the insulation lay... | Class I | St Jude Medical Cardiac Rhythm Management Division |
| Aug 18, 2015 | Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid... | Some devices exhibit backup VVI operation due to a backup reset. | Class II | St Jude Medical Cardiac Rhythm Management Division |
| Dec 18, 2014 | Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software ver... | Transmitter may initiate a software reset resulting in backup operation in some implanted St. Jud... | Class II | St Jude Medical Cardiac Rhythm Management Division |
| Nov 25, 2014 | TactiSys Quartz Pack, PN-004 400. For percutaneous catheter radiofrequen... | A configuration update needs to be done on TactiSys to appropriately recognize all TactiCath cath... | Class II | St Jude Medical |
| Oct 14, 2014 | St Jude Medical, 10F Fast-Cath Trio" Hemostasis Introducer, REF # 406308, St... | St. Jude Medical is conducting a voluntary recall of SMJ Batch # 4641580 of the Fast-Cath Trio" H... | Class II | St Jude Medical |
| Oct 14, 2014 | St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Mo... | St. Jude Medical is performing a voluntary recall of batch 4671318, model number 401353 of the Re... | Class II | St Jude Medical |
| Aug 19, 2014 | Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD... | An anomaly may result in delayed, partial, or no delivery of high voltage therapy. Internal damag... | Class II | St Jude Medical Cardiac Rhythm Management Division |
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.