Browse Device Recalls

1,694 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,694 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 1,694 FDA device recalls.

Clear
DateProductReasonClassFirm
Jan 17, 2019 Medtronic implantable pulse generator: Versa, Dual chamber rate responsive p... A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 ... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 17, 2019 MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices The Medtronic CareLink Encore 29901 programmer system is comprised of prescription devices indica... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 17, 2019 Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD):... A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 ... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 17, 2019 MEDTRONIC CARELINK 2090 programmer There is an error in how the programmer calculates and displays the remaining longevity value dur... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 17, 2019 vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1... A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 ... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 17, 2019 Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamb... A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 ... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 17, 2019 Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer There is a potential for an electrical short circuit to develop in a subset of 479 Model 26907 po... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 17, 2019 Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): ... A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 ... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Dec 6, 2018 Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and RE... Under certain circumstances, the percutaneous pin adapter used with the StealthAir Frame Assembly... Class II Medtronic Navigation, Inc.
Nov 27, 2018 RESERVOIR "Y" ADAPTER, (a) BT920 (b) BT926 Suction and Anticoagulation ... Medtronic discovered that certain Y-connectors included in the suction lines have exhibited teari... Class II Medtronic Perfusion Systems
Nov 27, 2018 SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and Antic... Medtronic discovered that certain Y-connectors included in the suction lines have exhibited teari... Class II Medtronic Perfusion Systems
Nov 19, 2018 Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600... HVAD Battery Charger units manufactured with wrong inductors. Class II Heartware, Inc.
Oct 5, 2018 Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Prod... The firm is issuing this voluntary removal following receipt of reports of parastomal mesh failur... Class II Covidien LLC
Oct 3, 2018 Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 60258... Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expe... Class II Medtronic Inc.
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

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.