Browse Device Recalls
1,708 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,708 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 1,708 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 4, 2021 | Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B). ... | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... | Class I | Medtronic Perfusion Systems |
| Feb 4, 2021 | Medtronic Custom Pack Infant Tubingset Pixie Flow 0,8->1,5-1,8 1/B (PERFUSION... | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... | Class I | Medtronic Perfusion Systems |
| Feb 3, 2021 | Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR,... | A small percentage of implanted cardiac devices, from a well-defined subset, may experience a sho... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Feb 3, 2021 | Implantable cardioverter defibrillators (ICD) with cardiac resynchronization ... | A small percentage of implanted cardiac devices, from a well-defined subset, may experience a sho... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jan 15, 2021 | Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35 | Sterility may be compromised due to an unsealed pouch | Class II | Medtronic Vascular |
| Jan 15, 2021 | Medtronic 6F Launcher Guide Catheter 100 cm JR 4.0 Model Number: LA6JR40 | Sterility may be compromised due to an unsealed pouch | Class II | Medtronic Vascular |
| Jan 15, 2021 | Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375 | Sterility may be compromised due to an unsealed pouch | Class II | Medtronic Vascular |
| Jan 15, 2021 | Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30 | Sterility may be compromised due to an unsealed pouch | Class II | Medtronic Vascular |
| Jan 11, 2021 | Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the foll... | Potential for variation in radiopaque marking visibility under radiographic imaging for adjustabl... | Class II | Medtronic Neurosurgery |
| Jan 11, 2021 | Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the... | Potential for variation in radiopaque marking visibility under radiographic imaging for adjustabl... | Class II | Medtronic Neurosurgery |
| Jan 11, 2021 | Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II V... | Potential for variation in radiopaque marking visibility under radiographic imaging for adjustabl... | Class II | Medtronic Neurosurgery |
| Dec 16, 2020 | REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.0, CE ... | Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the de... | Class II | Medtronic Neurosurgery |
| Dec 16, 2020 | REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE ... | Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the de... | Class II | Medtronic Neurosurgery |
| Dec 16, 2020 | REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level 2.0, CE ... | Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the de... | Class II | Medtronic Neurosurgery |
| Dec 8, 2020 | Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, Sterile, Rx Only.... | There is a potential for a defect on the seal of the outer pouch of catheters. The defect may com... | Class II | Medtronic Neurosurgery |
| Dec 8, 2020 | Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only.... | There is a potential for a defect on the seal of the outer pouch of catheters. The defect may com... | Class II | Medtronic Neurosurgery |
| Dec 8, 2020 | Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, Sterile, Rx Only.... | There is a potential for a defect on the seal of the outer pouch of catheters. The defect may com... | Class II | Medtronic Neurosurgery |
| Nov 19, 2020 | Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, ... | Pumps manufactured with impellers from a subset of lots from a single supplier are failing to ini... | Class I | Heartware, Inc. |
| Nov 19, 2020 | Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC ... | A software anomaly in the A620 Patient Programmer application was identified that results in fail... | Class II | Medtronic Neuromodulation |
| Nov 15, 2020 | Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditi... | Under rare circumstances, the component may be susceptible to a failure mechanism that could impa... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Nov 15, 2020 | Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable ca... | Under rare circumstances, the component may be susceptible to a failure mechanism that could impa... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Nov 15, 2020 | Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual cha... | Under rare circumstances, the component may be susceptible to a failure mechanism that could impa... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Nov 12, 2020 | Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Progra... | A710 Intellis Clinician Application has a software issue that can result in the inability to prog... | Class II | Medtronic Neuromodulation |
| Nov 12, 2020 | CareLink Personal Software Therapy Management Software Tool for Diabetes Car... | Incomplete basal rate information may be transmitted leading to a potential for inappropriate cha... | Class II | Medtronic Inc. |
| Nov 5, 2020 | Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization... | Manufacturing error that may have resulted in a cathode component being out of specification. Al... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Oct 23, 2020 | Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23, ... | Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant ball... | Class II | Medtronic Heart Valves Division |
| Oct 23, 2020 | Evolut (TM) PRO+ System. With the following model numbers: a. EVPROPLUS... | Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant ball... | Class II | Medtronic Heart Valves Division |
| Oct 23, 2020 | Evolut (TM) PRO System. With the following model numbers: a. EVOLUTPRO-... | Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant ball... | Class II | Medtronic Heart Valves Division |
| Oct 12, 2020 | Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF... | There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFle... | Class II | MEDTRONIC ATS MEDICAL, INC. |
| Oct 12, 2020 | Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF... | There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFle... | Class II | MEDTRONIC ATS MEDICAL, INC. |
| Oct 12, 2020 | Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM... | There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFle... | Class II | MEDTRONIC ATS MEDICAL, INC. |
| Oct 12, 2020 | Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF... | There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFle... | Class II | MEDTRONIC ATS MEDICAL, INC. |
| Aug 25, 2020 | Rashkind Balloon Septostomy Catheter, 5F, Closed end, 50 cm, Pediatric, Singl... | Subsequent failure of catheters in the field and failed quality testing | Class I | Medtronic Vascular |
| Aug 25, 2020 | Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Singl... | Subsequent failure of catheters in the field and failed quality testing | Class I | Medtronic Vascular |
| Aug 25, 2020 | Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, ... | Subsequent failure of catheters in the field and failed quality testing | Class I | Medtronic Vascular |
| Jul 17, 2020 | Restore Clinician Programmer Application Software, model number A71100, used... | The original version of the A71100 Restore Clinician Programmer Application has been identified t... | Class II | Medtronic Neuromodulation |
| Jul 15, 2020 | The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by pat... | As a result of the release of new software version to CareLink Personal website, the IOS app for ... | Class II | Medtronic Inc. |
| Jul 13, 2020 | Medtronic SynchroMed, Model A10 | The previous software application version (1.1.300) is missing a decimal separator (a comma) for ... | Class II | Medtronic Inc. |
| Jun 12, 2020 | Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is ind... | During internal testing execution of the next generation of Integrated Power Console (IPC) protot... | Class II | Medtronic Xomed, Inc. |
| Jun 8, 2020 | Accurian RF Ablation, Cannula pk, Accurian, 100mm, 18G, 10mm, CS Product Numb... | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 8, 2020 | Accurian RF Ablation, Cannula pk, Accurian, 150mm, 18G, 10mm, CS Product Numb... | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 8, 2020 | Accurian RF Ablation, Cannula pk, Accurian, 100mm, 20G, 10mm, CS Product Numb... | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 8, 2020 | Accurian RF Ablation,Cannula pk, Accurian, 100mm, 22G, 10mm, SS Product Numbe... | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 8, 2020 | Accurian RF Ablation, Cannula pk, Accurian, 100mm, 22G, 5mm, CS Product Numbe... | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 8, 2020 | Accurian RF Ablation, Cannula pk, Accurian, 150mm, 20G, 10mm, CS Product Numb... | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 5, 2020 | StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437... | There is a potential for specific camera units to be affected by a characterization issue during ... | Class II | Medtronic Navigation, Inc. |
| Jun 4, 2020 | Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Azure S SR MRI, Model Number W3SR01 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
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.