Medical devices, 2019
Shortlist up to four to read them side by side.
2,801 medical device recalls FDA’s Enforcement Report published in 2019, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
2,801of 2,801 medical device recallsshown with your filters
The list
- Medical device recall Maquet VOLISTA StandOP Surgical Lights Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet VOLISTA StandOP Surgical Lights Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet VOLISTA StandOP Surgical Lights Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet VOLISTA StandOP Surgical Lights Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet VOLISTA StandOP Surgical Lights Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet VOLISTA StandOP Surgical Lights Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet VOLISTA StandOP Surgical Lights Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet VOLISTA StandOP Surgical Lights Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet VOLISTA StandOP Surgical Lights Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet VOLISTA StandOP Surgical Lights Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet VOLISTA StandOP Surgical Lights Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 5L GP Bath Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Kentucky and Pennsylvania
- Medical device recall Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 10L GP Bath Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Kentucky and Pennsylvania
- Medical device recall Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 20L GP Bath Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Kentucky and Pennsylvania
- Medical device recall Thermo Scientific General Purpose Dynamic Bath Precision 10L GP Bath Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Kentucky and Pennsylvania
- Medical device recall Thermo Scientific General Purpose Dynamic Bath Precision 20L GP Bath Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Kentucky and Pennsylvania
- Medical device recall Thermo Scientific General Purpose Dynamic Bath Precision 2L-Shallow GP Bath Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Kentucky and Pennsylvania
- Medical device recall Thermo Scientific General Purpose Dynamic Bath Precision 5 & 10L Dual GP Bath Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Kentucky and Pennsylvania
- Medical device recall Thermo Scientific General Purpose Dynamic Bath Precision 28L GP Bath Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Kentucky and Pennsylvania
- Medical device recall Thermo Scientific General Purpose Dynamic Bath Precision 5L GP Bath Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Kentucky and Pennsylvania
- Medical device recall ECG Trunk Cables: REF/Catalog Number Description 2106305-001 ECG Trunk Cable, 3/5-lead, AHA, 3.6 m/12 ft.… ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the… Class IIIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 3, 2019ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ECG leadwire sets: REF/Catalog Number Description 2106389-001 ECG Leadwire set, 5-lead, grouped, grabber,… ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the… Class IIIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 3, 2019ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Replacement leadwires with grabber ends: REF/Catalog Number Description 2106388-005 Replacement ECG Leadwire,… ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the… Class IIIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 3, 2019ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Leadwire sets with snap ends: REF/Catalog Number Description 2106381-001 ECG Leadwire set, 5-lead, snap, AHA,… ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the… Class IIIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 3, 2019ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Replacement ECG leadwires with snap ends REF/Catalog Number Description 2106386-101 Replacement ECG Leadwire,… ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the… Class IIIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 3, 2019ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Mosaic 310 Bioprosthesis, Mitral Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide, and New Jersey, New York and Tennessee named
- Medical device recall Mosaic 310 Bioprosthesis, Mitral Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide, and New Jersey, New York and Tennessee named
- Medical device recall Hancock II T510 Bioprosthesis, Mitral Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide, and New Jersey, New York and Tennessee named
- Medical device recall Hancock II T510 Bioprosthesis, Mitral Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide, and New Jersey, New York and Tennessee named
- Medical device recall Hancock II T510 Bioprosthesis, Mitral Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide, and New Jersey, New York and Tennessee named
- Medical device recall Centricity PACS-IW with Universal Viewer version 5.0 There is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer. Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centricity Universal Viewer with PACS-IW foundation 6.0 There is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer. Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EPi-Sense Guided Coagulation System with Visitrax The sterile package seal for the Epi-Sense Guided Coagulation System may be compromised, and has a worst-case reasonable harm of infection if used. Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 25cm Shaft Observed reported incidence rate for harm associated with intraoperative bleeding Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft Observed reported incidence rate for harm associated with intraoperative bleeding Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft Observed reported incidence rate for harm associated with intraoperative bleeding Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RNeasy DSP FFPE Kit The deparaffinization solution contains a contaminant, which leads to reduced lysis efficiency of the affected lot, resulting in significantly reduced yields… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Indiana, Massachusetts, North Carolina, New York, Rhode Island and Texas named
- Medical device recall PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system. There is a potential for a discrepant target position when using 3D3D matching mode in PIAS (Positioning Image Analysis System) software installed in the… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereArizona, Minnesota and Tennessee
- Medical device recall Discovery PET/CT 610 Product Usage: The systems are intended for head and whole body attenuation corrected… GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Discovery PET/CT 710 Product Usage: The systems are intended for head and whole body attenuation corrected… GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Optima PET/CT 560, 560FX Product Usage: The systems are intended for head and whole body attenuation… GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Discovery IQ Product Usage: The systems are intended for head and whole body attenuation corrected Positron… GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Discovery Ml Product Usage: The systems are intended for head and whole body attenuation corrected Positron… GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Discovery Ml DR Product Usage: The systems are intended for head and whole body attenuation corrected… GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/50cm Multiple complaints were received for balloons bursting below the rated burst pressure. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 26, 2019ClassClass IStatusTerminatedWhereNationwide, and Florida, Ohio and Washington named
- Medical device recall Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/80cm Multiple complaints were received for balloons bursting below the rated burst pressure. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 26, 2019ClassClass IStatusTerminatedWhereNationwide, and Florida, Ohio and Washington named
- Medical device recall Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/135cm Multiple complaints were received for balloons bursting below the rated burst pressure. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 26, 2019ClassClass IStatusTerminatedWhereNationwide, and Florida, Ohio and Washington named
- Medical device recall Hudson RCI Sheridan LTS This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IStatusTerminatedWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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