Browse Device Recalls
39,969 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,969 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 39,969 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 10, 2023 | ICD-VR VISIA AF S US/OUS DF4, Model Number DVAC3D4; Implantable Cardioverter... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | CRTD CROME HF QUAD MRI IS4 DF1, Model Number DTPC2Q1; Implantable Cardiovert... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | ICD-DR DDMD3D1 PRIMO MRI, Model Number DDMD3D1; Implantable Cardioverter Def... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | ICD-VR DVBB2D4 EVERA XT DF4 INTL, Model Number DVBB2D4; Implantable Cardiove... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | ICD-VR DVBB2D1 EVERA XT IS1/DF1 INTL, Model Number DVBB2D1; Implantable Card... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | ICD-VR DVMB2D4 EVERA MRI XT DF4 INTL, Model Number DVMB2D4; Implantable Card... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | ICD-VR DVMB1D4 EVERA MRI XT DF4 US, Model Number DVMB1D4; Implantable Cardio... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | CRT-D DTBC2D1 BRAVA IS1/DF1 INTL, Model Number DTBC2D1; Implantable Cardiove... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004 | Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-S... | Class II | Fresenius Kabi USA, LLC |
| May 10, 2023 | PushTracker E2 component utilized with the SmartDrive MX2+ Power Assist Devic... | When multiple processes are running on the watch's Central Processing Unit (CPU), the application... | Class II | Permobil |
| May 10, 2023 | ICD-VR DVBC3D4 EVERA S DF4 GLOB, Model Number DVBC3D4; Implantable Cardiover... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | CRT-D DTBB1QQ VIVA QUAD S IS4/DF4 US, Model Number DTBB1QQ; Implantable Card... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1; Implantable Ca... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | CRT-D DTBA1D1 VIVA XT IS1/DF1 US, Model Number DTBA1D1; Implantable Cardiove... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | ICD CROME VR MRI IS1 DF1, Model Number DVPC3D1; Implantable Cardioverter Def... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | ICD-DR DDBB2D4 EVERA XT IS1/DF4 INTL, Model Number DDBB2D4; Implantable Card... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | ICD COBALT XT HF QUAD OUS, Model Number DTPA2QQG; Implantable Cardioverter D... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | CRT-D DTBC2QQ BRAVA QUAD IS4/DF4 INTL, Model Number DTBC2QQ; Implantable Car... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | ICD-VR VISIA AF S US/OUS IS1/DF1, Model Number DVAC3D1; Implantable Cardiove... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | CRTD DTMB1D4 AMPLIA MRI US DF4, Model Number DTMB1D4; Implantable Cardiovert... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | CRTD DTMC1D1 COMPIA MRI US DF1, Model Number DTMC1D1; Implantable Cardiovert... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | CRTD DTMA2D1 CLARIA MRI OUS DF1, Model Number DTMA2D1; Implantable Cardiover... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | CRTD CROME HF MRI IS1 DF4, Model Number DTPC2D4; Implantable Cardioverter De... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | CRT-D DTBA1Q1 VIVA QUAD XT IS4/DF1 US, Model Number DTBA1Q1; Implantable Car... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | CRT-D DTBA2QQ VIVA QUAD XT IS4/DF4 INTL, Model Number DTBA2QQ; Implantable C... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | CRT-D DTBB2D4 VIVA S IS1/DF4 INTL, Model Number DTBB2D4; Implantable Cardiov... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | ICD DDPA2D1G COBALT XT DR MRI DF1 GOLD, Model Number DDPA2D1G; Implantable C... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; Implantable Card... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 9, 2023 | vRad PACS with Mammography | The error resulted in intermittent failure of current (primary) radiology study images not displa... | Class II | Virtual Radiologic Corp. |
| May 9, 2023 | QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and ... | If cartridges of the affected Serial numbers (SNs) are used, in most cases, the error codes 0xY00... | Class II | Qiagen GmbH |
| May 8, 2023 | VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VI... | Potential to cause biased results in the upper end of the reportable range for the quantitative m... | Class II | Ortho-Clinical Diagnostics |
| May 8, 2023 | FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems... | Due to manufacturing issue, panels may result in false negative results. | Class II | BioFire Diagnostics, LLC |
| May 8, 2023 | BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IV... | Due to manufacturing issue, panels may result in false negative results. | Class II | BioFire Diagnostics, LLC |
| May 8, 2023 | Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12,... | Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer c... | Class II | Galt Medical Corporation |
| May 8, 2023 | Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 | Defibrillator/pacemaker module (DPM) may encounter a problem causing communication from the Mainb... | Class II | Remote Diagnostic Technologies Ltd. |
| May 8, 2023 | Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16 | Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer c... | Class II | Galt Medical Corporation |
| May 5, 2023 | bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Vent... | Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bell... | Class II | Vyaire Medical |
| May 5, 2023 | bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ven... | Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bell... | Class II | Vyaire Medical |
| May 5, 2023 | Elekta Medical Linear Accelerator (ELMA) included in the below platforms: ... | A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC... | Class II | Elekta, Inc. |
| May 4, 2023 | BETTA LINK SR REUSABLE FISHMOUTH GUIDE-Intended for use in soft tissue to bon... | Drill guides might bend when axial forces are applied by surgeon during procedure and result in p... | Class II | T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. |
| May 4, 2023 | Single Use Repositionable Clip QUICKCLIP PRO 230CM 5/BX- Intended for hemosta... | Complaints on clip deployment occurring during clinical procedures, leading to hazardous situatio... | Class II | Olympus Corporation of the Americas |
| May 4, 2023 | Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemos... | Complaints on clip deployment occurring during clinical procedures, leading to hazardous situatio... | Class II | Olympus Corporation of the Americas |
| May 4, 2023 | Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemosta... | Complaints on clip deployment occurring during clinical procedures, leading to hazardous situatio... | Class II | Olympus Corporation of the Americas |
| May 4, 2023 | Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-080... | The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 inc... | Class III | Datascope Corp. |
| May 4, 2023 | BETTA LINK SR KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fi... | Drill guides might bend when axial forces are applied by surgeon during procedure and result in p... | Class II | T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. |
| May 4, 2023 | Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed qua... | Delay in reporting results due to Quality Controls running high outside of range. Target value an... | Class III | Randox Laboratories Ltd. |
| May 4, 2023 | Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemos... | Complaints on clip deployment occurring during clinical procedures, leading to hazardous situatio... | Class II | Olympus Corporation of the Americas |
| May 4, 2023 | Betta Link LG Reusable ProngED Guide - Intended for use in soft tissue to bon... | Drill guides might bend when axial forces are applied by surgeon during procedure and result in p... | Class II | T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. |
| May 4, 2023 | BETTA LINK LG KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fi... | Drill guides might bend when axial forces are applied by surgeon during procedure and result in p... | Class II | T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. |
| May 4, 2023 | BETTA LINK SR REUSABLE PRONGED GUIDE- Intended for use in soft tissue to bone... | Drill guides might bend when axial forces are applied by surgeon during procedure and result in p... | Class II | T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. |
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.