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 |
|---|---|---|---|---|
| Dec 12, 2022 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosur... | An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the A... | Class II | Medtronic Perfusion Systems |
| Dec 12, 2022 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosur... | An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the A... | Class II | Medtronic Perfusion Systems |
| Dec 12, 2022 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosur... | An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the A... | Class II | Medtronic Perfusion Systems |
| Dec 12, 2022 | Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with... | An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the A... | Class II | Medtronic Perfusion Systems |
| Dec 8, 2022 | RadiaLux Lighted Retractor (Pink), REF: 50-101-1 | Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of conta... | Class II | Medtronic Navigation, Inc. |
| Dec 3, 2022 | Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... | Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502... | Class II | Medtronic Neuromodulation |
| Dec 3, 2022 | Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... | Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502... | Class II | Medtronic Neuromodulation |
| Dec 3, 2022 | Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... | Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502... | Class II | Medtronic Neuromodulation |
| Dec 3, 2022 | Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... | Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502... | Class II | Medtronic Neuromodulation |
| Dec 3, 2022 | Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... | Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502... | Class II | Medtronic Neuromodulation |
| Nov 29, 2022 | HeartWare HVAD Pump Kit, REF 1104JP | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare HVAD Pump Kit, REF 1205 | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare Model 1102 | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare HVAD Pump Kit, REF MCS1705PU | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare HVAD Pump Kit, REF 1104 | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare HVAD Pump Kit, REF 1103 | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare Model 1101 | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare HVAD Pump Kit, REF 1104CA-CLIN | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare Model 1100 | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 21, 2022 | Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the ... | An app, part of a continuous glucose monitoring system, for use with smartphone devices may autom... | Class II | Medtronic MiniMed |
| Oct 14, 2022 | Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10M... | Due to a defect in the outer pouch sterile seal | Class II | Medtronic Navigation, Inc. |
| Sep 28, 2022 | Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLO... | Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential ... | Class II | Covidien, LP |
| Sep 28, 2022 | Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA00... | Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential ... | Class II | Covidien, LP |
| Sep 20, 2022 | Insulin Pump/Model: MiniMed 630G/ MMT-1715, MMT-1755, MMT-1754; MiniMed 67... | Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems... | Class II | Medtronic MiniMed |
| Sep 20, 2022 | Insulin Pump/Model: MiniMed 620G/ MMT-1750 MiniMed 640G/ MMT-1711, MMT-1712... | Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems... | Class II | Medtronic MiniMed |
| Aug 19, 2022 | Puritan Bennett 560 Ventilator, PB560, CFN 4096600 | Medtronic has confirmed six reports from customers outside the US where the ventilator became ino... | Class II | Covidien Llc |
| Jul 26, 2022 | Vanta Clinician Programmer Application, Model A71200. For programming of the... | Potential for Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 to display an Unex... | Class II | Medtronic Neuromodulation |
| Jul 26, 2022 | Vanta Clinician Programmer Application, Model A71200. For programming of the... | Potential communication issue in which the Vanta Clinician Programmer Application (CP App) A71200... | Class II | Medtronic Neuromodulation |
| Jul 14, 2022 | EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System | Update to IFU provides a manual deployment workaround method to help mitigate potential harms rel... | Class II | Medtronic Inc. |
| Jun 24, 2022 | Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wi... | Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" ... | Class II | Medtronic Inc |
| Jun 22, 2022 | Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization... | There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 22, 2022 | Cobalt Implantable Cardioverter Defibrillators: a. Cobalt VR ICD, Model Numbe... | There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 22, 2022 | Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization ... | There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 22, 2022 | Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization... | There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 22, 2022 | Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Nu... | There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 22, 2022 | Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers... | There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 27, 2022 | LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device. | There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepanc... | Class II | Medtronic Neuromodulation |
| May 23, 2022 | MiniMed 630G Insulin Pump (U.S. and Canada Version) | Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... | Class II | Medtronic MiniMed |
| May 23, 2022 | MiniMed 620G Insulin Pump (O.U.S. version) | Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... | Class II | Medtronic MiniMed |
| May 23, 2022 | MiniMed 770G Insulin Pump (U.S. and O.U.S. Version) | Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... | Class II | Medtronic MiniMed |
| May 23, 2022 | MiniMed 780G Insulin Pump (O.U.S. Version) | Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... | Class II | Medtronic MiniMed |
| May 23, 2022 | MiniMed 670G Insulin Pump (U.S. and O.U.S. Version) | Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... | Class II | Medtronic MiniMed |
| May 23, 2022 | MiniMed 640G Insulin Pump (O.U.S. Version) | Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... | Class II | Medtronic MiniMed |
| May 23, 2022 | MiniMed 720G Insulin Pump (O.U.S. Version) | Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... | Class II | Medtronic MiniMed |
| May 23, 2022 | MiniMed 740G Insulin Pump (O.U.S. Version) | Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... | Class II | Medtronic MiniMed |
| May 5, 2022 | HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular As... | Batteries for the HVAD system have a weld defect affecting internal components within the HVAD ba... | Class I | Medtronic Inc |
| May 3, 2022 | NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2 | Software anomaly was identified. | Class II | Medtronic Xomed, Inc. |
| May 3, 2022 | NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2 | Software anomaly was identified. | Class II | Medtronic Xomed, Inc. |
| Apr 29, 2022 | NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J ... | The firm received reports of events related to airway obstruction while using NIM Standard Reinfo... | Class I | Medtronic Xomed, Inc. |
| Apr 29, 2022 | NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229... | The firm received reports of events related to airway obstruction while using NIM Standard Reinfo... | Class I | Medtronic Xomed, 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.