Browse Device Recalls
68 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 68 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 68 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 22, 2025 | Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Cathet... | These lots of reprocessed catheters may contain small particles of residual material. If affected... | Class I | Medline Industries, LP |
| Jul 14, 2025 | Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic ... | Specific lots of reprocessed electrophysiology catheters may contain small residual particulates. | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 3, 2025 | CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital S... | Due to issues associated with data migration of patient information and results to a Cloud servic... | Class II | St. Jude Medical |
| Nov 6, 2024 | Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN... | Due to a data migration from on-premises server to the cloud environment, some customers reported... | Class II | St. Jude Medical |
| Oct 5, 2024 | CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Ele... | As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) re... | Class II | St. Jude Medical |
| Oct 5, 2024 | CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial El... | As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) re... | Class II | St. Jude Medical |
| Apr 30, 2024 | St. Jude Medical Agilis NxT Steerable Introducer, REF 408309 | One lot of product has dilators that are too short and will not extend outside the introducer she... | Class II | St. Jude Medical |
| Dec 18, 2023 | TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F ... | When the catheters are used with the EnSiteX EP System, the system does not correctly recognize t... | Class II | St. Jude Medical, Atrial Fibrillation Division,... |
| Oct 4, 2023 | CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used fo... | Potential for damaged and frayed power connector plug with repeated bending or manipulation beyon... | Class II | St. Jude Medical |
| Feb 7, 2023 | CardioMEMS HF System Patient Electronics System (PES), Model number CM1100, T... | Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Model... | Class II | St. Jude Medical |
| Feb 7, 2023 | CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The ... | Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at hi... | Class II | St. Jude Medical |
| Feb 7, 2023 | CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, T... | Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Model... | Class II | St. Jude Medical |
| Feb 7, 2023 | CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, T... | Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Model... | Class II | St. Jude Medical |
| Feb 7, 2023 | CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, ... | Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Model... | Class II | St. Jude Medical |
| Feb 7, 2023 | CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, The ... | Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at hi... | Class II | St. Jude Medical |
| Feb 7, 2023 | CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The ... | Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at hi... | Class II | St. Jude Medical |
| Jun 17, 2022 | Merlin.net model MN5000 Software | The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrog... | Class II | St. Jude Medical, Cardiac Rhythm Management Div... |
| Jun 17, 2022 | Merlin PCS 3650 programmer Model 3330 software | There is a potential for programmer software (Merlin PCS) and remote monitoring software applicat... | Class II | St. Jude Medical, Cardiac Rhythm Management Div... |
| Jun 17, 2022 | Merlin 2 PCS MER37000 programmer Model MER3400 software | The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrog... | Class II | St. Jude Medical, Cardiac Rhythm Management Div... |
| Mar 10, 2022 | Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q | Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to e... | Class II | St. Jude Medical, Cardiac Rhythm Management Div... |
| Mar 10, 2022 | Merlin PCS 3650 programmer Model 3330 software | Due to a programmer software anomaly under very specific circumstance when executing a pacing cap... | Class II | St. Jude Medical, Cardiac Rhythm Management Div... |
| Mar 10, 2022 | Merlin 2 PCS MER3700 programmer Model MER3400 software | Due to a programmer software anomaly under very specific circumstance when executing a pacing cap... | Class II | St. Jude Medical, Cardiac Rhythm Management Div... |
| Mar 10, 2022 | Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q | Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to e... | Class II | St. Jude Medical, Cardiac Rhythm Management Div... |
| Mar 10, 2022 | Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q | Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to e... | Class II | St. Jude Medical, Cardiac Rhythm Management Div... |
| Mar 15, 2021 | ASSURITY Pulse Generator REF PM**** SN ********* ST. JUDE MEDICAL Assur... | Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufact... | Class I | St. Jude Medical, Cardian Rhythm Management Div... |
| Mar 15, 2021 | ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rh... | Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufact... | Class I | St. Jude Medical, Cardian Rhythm Management Div... |
| Aug 24, 2020 | Inquiry Steerable Diagnostic Catheter, REF: IBI-87002 - Product Usage: INDICA... | Steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contain... | Class II | Irvine Biomedical Inc, a St. Jude Medical Co. |
| Aug 24, 2020 | Inquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage: INDICA... | Steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contain... | Class II | Irvine Biomedical Inc, a St. Jude Medical Co. |
| Mar 27, 2020 | Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Ju... | A subset of temporary intracardiac ultrasound catheters are labeled with the incorrect expiration... | Class II | Stryker Sustainability Solutions |
| Feb 28, 2020 | Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The Merlin... | Internal testing of software identified software anomaly scenarios where if non-applicable shock ... | Class II | Abbott |
| Nov 19, 2018 | St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. ... | The device is unable to pair with the mobile app due to the device incorrectly determining the ce... | Class II | Abbott |
| Oct 11, 2018 | St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6... | The most proximal unsegmented electrode of the Deep Brain Stimulation leads, may be constructed w... | 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 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... |
| Mar 9, 2018 | Proclaim DRG Implantable Pulse Generator, Model Number 3664 | The firm received complaints of error messages that occurred during routine impedance checks on P... | Class II | St. Jude Medical, Inc. |
| Sep 12, 2017 | Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable... | Analysis of the difference between the actual device longevity and the battery indicator status p... | Class II | St. Jude Medical, Inc. |
| Sep 12, 2017 | Proclaim DRG Implantable Pulse Generator Model 3664 | Analysis of the difference between the actual device longevity and the battery indicator status p... | Class II | St. Jude Medical, Inc. |
| Sep 12, 2017 | Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Gener... | Analysis of the difference between the actual device longevity and the battery indicator status 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 | 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. |
| Jun 2, 2017 | St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Cur... | Inadequate seal due to lack of adhesive glue | Class I | Sterilmed Inc |
| Jun 2, 2017 | Proclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO ... | The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop... | Class II | St. Jude Medical, Inc. |
| Jun 2, 2017 | Infinity 5, Implantable Pulse Generator, REF 6661, Rx only, STERILE EO Pro... | The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop... | Class II | St. Jude Medical, Inc. |
| Jun 2, 2017 | Proclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO ... | The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop... | Class II | St. Jude Medical, Inc. |
| Jun 2, 2017 | Infinity 7, Implantable Pulse Generator, REF 6662, Rx only, STERILE EO Pro... | The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop... | Class II | St. Jude Medical, Inc. |
| Jun 2, 2017 | Infinity 5, Implantable Pulse Generator, REF 6660, Rx only, STERILE EO, P... | The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop... | Class II | St. Jude Medical, Inc. |
| Jun 2, 2017 | Infinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO Pro... | The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop... | Class II | St. Jude Medical, Inc. |
| Mar 30, 2017 | HeartMate¿ II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PC... | St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with ne... | Class I | Thoratec Corporation |
| Mar 30, 2017 | HeartMate¿ II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER,... | St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with ne... | Class I | Thoratec Corporation |
| Mar 30, 2017 | HeartMate¿ II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL... | St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with ne... | Class I | Thoratec 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.