Medical devices, 2023
Shortlist up to four to read them side by side.
2,477 medical device recalls FDA’s Enforcement Report published in 2023, 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 5, 2026.
2,477of 2,477 medical device recallsshown with your filters
The list
- Medical device recall ProCuity bed series Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall ProCuity bed series Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall ProCuity bed series Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall ProCuity bed series Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall ProCuity bed series Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall ProCurity bed series Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall ProCurity bed series Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall ProCurity bed series Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall DRX Revolution Mobile X-Ray System Unexpected failure of electrical components within the CPI generator. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CardioQuip Modular Cooler-Heater There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement Report15 statesnamed in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereAlabama, California, Connecticut, Florida, Iowa, Illinois, Indiana, Kentucky, New Jersey, Pennsylvania, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall CardioQuip Modular Cooler-Heater There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement Report15 statesnamed in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereAlabama, California, Connecticut, Florida, Iowa, Illinois, Indiana, Kentucky, New Jersey, Pennsylvania, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1. Pump not detected as connected to controller due to software issue. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 13, 2023ClassClass IIStatusTerminatedWhereArizona, California, Florida, New York and Virginia
- Medical device recall Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1. Pump not detected as connected to controller due to software issue. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 13, 2023ClassClass IIStatusTerminatedWhereArizona, California, Florida, New York and Virginia
- Medical device recall ELEKTA LIMITED Precise Digital Accelerator Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI… Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall ELEKTA LIMITED Elekta Synergy Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI… Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall ELEKTA LIMITED Elekta Synergy Platform Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI… Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall ELEKTA LIMITED Versa HD Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI… Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall ELEKTA LIMITED Elekta Infinity Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI… Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall ELEKTA AXESSE Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI… Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Monarch Platform Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement Report34 statesnamed in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereAlaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Wisconsin and West Virginia
- Medical device recall Monarch Platform Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement Report34 statesnamed in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereAlaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Wisconsin and West Virginia
- Medical device recall Monarch Platform Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement Report34 statesnamed in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereAlaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Wisconsin and West Virginia
- Medical device recall BIOFIRE Blood Culture Identification 2 (BCID2) Panel Routine quality control testing of affected blood culture identification panel with affected control panel may need to be amended, due to control… Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Freedom Boom models series: F110, F120, F130, F320, F330, F350, F410, and F420 with built Weakened connection point on the adjustable suspension arm, potentially causing damage or a break. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement Report36 statesnamed in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall NovoTHOR Gen 2.0 whole body red light therapy bed Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Hawaii, Iowa, Idaho, Illinois, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, Ohio, Oregon, Texas, Utah, Virginia and West Virginia named
- Medical device recall G041 POD, THOR NOVO GEN 2.0 XL whole body red light therapy bed Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Hawaii, Iowa, Idaho, Illinois, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, Ohio, Oregon, Texas, Utah, Virginia and West Virginia named
- Medical device recall NovoTHOR Gen 2.5 Regular whole body red light therapy bed Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Hawaii, Iowa, Idaho, Illinois, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, Ohio, Oregon, Texas, Utah, Virginia and West Virginia named
- Medical device recall NovoTHOR Gen 2.5 XL whole body red light therapy bed Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Hawaii, Iowa, Idaho, Illinois, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, Ohio, Oregon, Texas, Utah, Virginia and West Virginia named
- Medical device recall QUANTUM TTC BILIARY BALLOON DILATOR Nonconforming devices while manufactured correctly, do not comply to their design requirements. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall QUANTUM TTC BILIARY BALLOON DILATOR Nonconforming devices while manufactured correctly, do not comply to their design requirements. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall QUANTUM TTC BILIARY BALLOON DILATOR Nonconforming devices while manufactured correctly, do not comply to their design requirements. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall QUANTUM TTC BILIARY BALLOON DILATOR Nonconforming devices while manufactured correctly, do not comply to their design requirements. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall QUANTUM TTC BILIARY BALLOON DILATOR Nonconforming devices while manufactured correctly, do not comply to their design requirements. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall QUANTUM TTC BILIARY BALLOON DILATOR Nonconforming devices while manufactured correctly, do not comply to their design requirements. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall QUANTUM TTC BILIARY BALLOON DILATOR Nonconforming devices while manufactured correctly, do not comply to their design requirements. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall EVO+VISIAN Implantable Collamer Lens Their is a potential that intraocular implant devices may not meet specifications. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement Report38 statesnamed in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall EVO+VISIAN Implantable Collamer Lens Their is a potential that intraocular implant devices may not meet specifications. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement Report38 statesnamed in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall EVO+VISIAN Implantable Collamer Lens Their is a potential that intraocular implant devices may not meet specifications. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement Report38 statesnamed in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall EVO +VISIAN Implantable Collamer Lens Their is a potential that intraocular implant devices may not meet specifications. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement Report38 statesnamed in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall EVO VISIAN Implantable Collamer Lens Their is a potential that intraocular implant devices may not meet specifications. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement Report38 statesnamed in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall EVO VISIAN Implantable Collamer Lens Their is a potential that intraocular implant devices may not meet specifications. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement Report38 statesnamed in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall EVO+VISIAN Implantable Collamer Lens Their is a potential that intraocular implant devices may not meet specifications. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement Report38 statesnamed in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall EVO+VISIAN Implantable Collamer Lens Their is a potential that intraocular implant devices may not meet specifications. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement Report38 statesnamed in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall EVO+VISIAN Implantable Collamer Lens Their is a potential that intraocular implant devices may not meet specifications. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement Report38 statesnamed in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall EVO+VISIAN Implantable Collamer Lens Their is a potential that intraocular implant devices may not meet specifications. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement Report38 statesnamed in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall EVO VISIAN Implantable Collamer Lens Their is a potential that intraocular implant devices may not meet specifications. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement Report38 statesnamed in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US) Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNo state named
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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