Browse Device Recalls
1,730 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,730 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 1,730 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 2, 2018 | Medtronic CareLink 2090 Programmer | Vulnerabilities have been identified in the SDN download process that may allow an individual wit... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Oct 2, 2018 | Medtronic CareLink Encore 29901 Programmer | Vulnerabilities have been identified in the SDN download process that may allow an individual wit... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Sep 27, 2018 | INFUSE Bone Graft X SMALL KIT REF 7510100 | The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sp... | Class II | Medtronic Sofamor Danek USA Inc |
| Sep 26, 2018 | StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cra... | An incorrect display of the Biopsy Depth Gauge graphical representation in the Guidance View usin... | Class I | Medtronic Navigation, Inc. |
| Sep 17, 2018 | Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ra... | O-arm 02 Imaging Systems correction to software version 4.1.0; new version of the user manual and... | Class II | Medtronic Navigation, Inc.-Littleton |
| Aug 30, 2018 | O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GER SYS PRODUCT GE... | Software anomalies were reported to affect the following system functionalities: startup and shut... | Class II | Medtronic Navigation, Inc.-Littleton |
| Aug 30, 2018 | O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230 SYSTEM 230V, M... | Software anomalies were reported to affect the following system functionalities: startup and shut... | Class II | Medtronic Navigation, Inc.-Littleton |
| Aug 30, 2018 | O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100 SYSTEM lOOV, M... | Software anomalies were reported to affect the following system functionalities: startup and shut... | Class II | Medtronic Navigation, Inc.-Littleton |
| Aug 30, 2018 | O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100R SYSTEM lOOV R... | Software anomalies were reported to affect the following system functionalities: startup and shut... | Class II | Medtronic Navigation, Inc.-Littleton |
| Aug 30, 2018 | O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027120 SYSTEM 120V, M... | Software anomalies were reported to affect the following system functionalities: startup and shut... | Class II | Medtronic Navigation, Inc.-Littleton |
| Aug 30, 2018 | O-arm 1000 2nd Edition Imaging System, BASE BASE OARM Bl70000027120R SYSTEM 1... | Software anomalies were reported to affect the following system functionalities: startup and shut... | Class II | Medtronic Navigation, Inc.-Littleton |
| Aug 30, 2018 | O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230R SYSTEM 230V R... | Software anomalies were reported to affect the following system functionalities: startup and shut... | Class II | Medtronic Navigation, Inc.-Littleton |
| Aug 30, 2018 | O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GERR SYS PRODUCT R... | Software anomalies were reported to affect the following system functionalities: startup and shut... | Class II | Medtronic Navigation, Inc.-Littleton |
| Aug 30, 2018 | O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK,... | Software anomalies were reported to affect the following system functionalities: startup and shut... | Class II | Medtronic Navigation, Inc.-Littleton |
| Aug 30, 2018 | O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027 SYSTEM PRODUCT, M... | Software anomalies were reported to affect the following system functionalities: startup and shut... | Class II | Medtronic Navigation, Inc.-Littleton |
| Aug 16, 2018 | Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35 | Medtronic has determined that the French size indicator on the inner pouch may incorrectly reflec... | Class III | Medtronic Vascular |
| Aug 8, 2018 | Extra corporeal circuit with bio-active surface. | Affected products failed a sterilization test. | Class II | Medtronic Perfusion Systems |
| Aug 7, 2018 | Minimed Model 500 Remote Control (MMT-500, MMT-500RU, MMT-500RUS, MMT-500RSE,... | There is a potential security vulnerability related to the use of the remote controller accessori... | Class I | Medtronic Inc. |
| Aug 7, 2018 | Minimed Model 503 Remote Transmitter (MMT-503, MMT-503EU, MMT-503NA, MMT-503U... | There is a potential security vulnerability related to the use of the remote controller accessori... | Class I | Medtronic Inc. |
| Jul 9, 2018 | Medtronic CD HORIZON Spinal System is intended to help provide immobilization... | This lot has incorrectly been laser marked both on the screw head itself as well as the data carr... | Class II | Medtronic Sofamor Danek USA Inc |
| Jul 4, 2018 | Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices. | The application may be closed by the operating system without alerting the user the app is no lon... | Class II | Medtronic Inc. |
| Jun 21, 2018 | Medtronic EnTrust Escudo D144VRC (OUS distribution) Product Usage: The imp... | Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Percepta CRT-P MRI SureScan, REF W1TR04 Product Usage: The CRT-P models a... | Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with A... | Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with At... | Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with A... | Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Medtronic EnTrust Escudo D144DRG (OUS distribution) Product Usage: The imp... | Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with At... | Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Percepta Quad CRT-P MRI SureScan, REF W4TR01 Product Usage: The CRT-P mod... | Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P mod... | Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models a... | Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 6, 2018 | Single Chamber Temporary External Pacemaker, Model 53401 | A subset of Medtronic Model 53401 Single Chamber External Pulse Generators (EPGs) may revert from... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 1, 2018 | Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1... | Inaccuracy of MR thermometry during MRI-guided laser ablation procedures using the Medtronic Visu... | Class II | Medtronic Navigation, Inc. |
| May 25, 2018 | Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (... | This voluntary recall is being conducted due to the curved tip introducer needle which is include... | Class II | Medtronic Neuromodulation |
| May 25, 2018 | Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a... | This voluntary recall is being conducted due to the curved tip introducer needle which is include... | Class II | Medtronic Neuromodulation |
| May 22, 2018 | Tri-Staple 2.0 Black Intelligent Reload for use with Signia stapling system 6... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| May 22, 2018 | Endo GIA 45mm Curved Tip Articulating Vascular/Medium Reload with Tri-Staple ... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| May 22, 2018 | Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm ... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| May 22, 2018 | Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling sys... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| May 22, 2018 | Endo GIA 45 mm Extra Thick Black Articulating Reload with Tri-Staple Technolo... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| May 22, 2018 | Endo GIA 60 mm Extra Thick Black Articulating Reload with Tri-Staple Technolo... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| May 22, 2018 | Endo GIA 60 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Tec... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| May 22, 2018 | Endo GIA 60 mm Articulating Medium/Thick Reload with Tri-StapleTechnology, It... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| May 22, 2018 | Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm ... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| May 22, 2018 | Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling sys... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| May 22, 2018 | Endo GIA 45 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Tech... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| May 22, 2018 | Endo GIA 45mm Gray Articulating Vascular Reload with Tri-Staple Technology, I... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| May 22, 2018 | Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling sys... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| May 22, 2018 | Endo GIA 45 mm Articulating Medium/Thick Reload with Tri-Staple Technology, I... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| May 16, 2018 | Contour Plus Link 2.4, Product Catalog Number: MMT-1151SK. wireless blood glu... | CONTOUR PLUS LINK 2.4 meter with an incorrect unit of measure was included into meter kits and di... | Class II | Medtronic 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.