Medical devices, 2020
Shortlist up to four to read them side by side.
3,055 medical device recalls FDA’s Enforcement Report published in 2020, 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.
3,055of 3,055 medical device recallsshown with your filters
The list
- Medical device recall Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Space between the device and the packaging permits excessive movement which could potentially lead to the displacement of the anchor s tip protector allowing… Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ClearCanvas RIS/PACS A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis. Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Synaptive ImageDrive Clinical A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis. Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ABL90 FLEX Analyzer The firm received reports of occurrences where the barcode reader misinterpreted the contents of a locally printed barcode label used for entering patient ID… Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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 and West Virginia named
- Medical device recall ABL90 FLEX PLUS Analyzer The firm received reports of occurrences where the barcode reader misinterpreted the contents of a locally printed barcode label used for entering patient ID… Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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 and West Virginia named
- Medical device recall Olympus Pleuravideoscope There was no data to validate that the identified endo-therapy devices were compatible with certain pleuravideoscope models. Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Olympus Pleuravideoscope There was no data to validate that the identified endo-therapy devices were compatible with certain pleuravideoscope models. Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle It has been determined that the manufacturing process may have left foreign material particulates on the finished device. Class IIFDA’s classApr 29, 2020in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereArizona, California and South Carolina
- Medical device recall Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle It has been determined that the manufacturing process may have left foreign material particulates on the finished device. Class IIFDA’s classApr 29, 2020in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereArizona, California and South Carolina
- Medical device recall Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle It has been determined that the manufacturing process may have left foreign material particulates on the finished device. Class IIFDA’s classApr 29, 2020in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereArizona, California and South Carolina
- Medical device recall Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Dilator/Transseptal Needle It has been determined that the manufacturing process may have left foreign material particulates on the finished device. Class IIFDA’s classApr 29, 2020in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereArizona, California and South Carolina
- Medical device recall Medivators Endo Smartcap Endoscope Tubing Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air… Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medivators Endo Smartcap Endoscope Tubing Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air… Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medivators Endo Smartcap Endoscope Tubing Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air… Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medivators Endo Smartcap Endoscope Tubing Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air… Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medivators EndoGator Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air… Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medivators EndoGator Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air… Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medivators Endo carry-on Procedure Kit Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air… Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Temperature Sensing 100% Silicone Foley Catheter Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters. Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereNationwide, and Illinois named
- Medical device recall Temperature Sensing 100% Silicone Foley Catheter Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters. Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereNationwide, and Illinois named
- Medical device recall Temperature Sensing 100% Silicone Foley Catheter Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters. Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereNationwide, and Illinois named
- Medical device recall Temperature Sensing 100% Silicone Foley Catheter Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters. Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereNationwide, and Illinois named
- Medical device recall Temperature Sensing 100% Silicone Foley Catheter Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters. Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereNationwide, and Illinois named
- Medical device recall Temperature Sensing 100% Silicone Foley Catheter Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters. Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereNationwide, and Illinois named
- Medical device recall Temperature Sensing 100% Silicone Foley Catheter Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters. Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereNationwide, and Illinois named
- Medical device recall Temperature Sensing 100% Silicone Foley Catheter Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters. Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereNationwide, and Illinois named
- Medical device recall Temperature Sensing 100% Silicone Foley Catheter Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters. Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereNationwide, and Illinois named
- Medical device recall Temperature Sensing 100% Silicone Foley Catheter Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters. Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereNationwide, and Illinois named
- Medical device recall Temperature Sensing 100% Silicone Foley Catheter Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters. Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereNationwide, and Illinois named
- Medical device recall Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human… Negative bias for the carbohydrate-deficient transferrin (CDT) measurement in comparison to the HPLC method, observed to occur after 15 months based on shelf… Class IIFDA’s classApr 29, 2020in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereIndiana, Kansas, Missouri, Ohio and Virginia
- Medical device recall PREVI Isola Insrument and PREVI Isola Printer spares PSUs (power supply units), P1028888-001 PSU (used in… The recall has been initiated due to potential for overheating or a fire hazard associated with the Zebra LP2824 Plus printer PSU (power supply unit) located… Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile There was a potential that a 25-gauge infusion cannula may be included within the procedure pak instead of a 20-gauge infusion cannula. Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile The retaining ring on the neck trials has a potential to fail interoperatively. Class IIFDA’s classApr 22, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedApr 22, 2020ClassClass IIStatusOngoingWhereCalifornia, Colorado, Maryland, Minnesota, Ohio, Texas and Washington
- Medical device recall NavLock Tracker *** Product was incorrectly assembled which could affect navigation accuracy of the device. Class IIFDA’s classApr 22, 2020in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedApr 22, 2020ClassClass IIStatusTerminatedWhereNew York
- Medical device recall Nitinol Thermocouple Electrode, 10 cm - Product Usage: The TCN Electrode is indicated for use in RF heat… The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with… Class IIFDA’s classApr 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedApr 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Missouri, Nevada, New York, Ohio, Oklahoma, Oregon, South Carolina, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Nitinol Thermocouple Electrode, 10 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for use in RF… The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with… Class IIFDA’s classApr 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedApr 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Missouri, Nevada, New York, Ohio, Oklahoma, Oregon, South Carolina, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Nitinol Thermocouple Electrode, 15 cm - Product Usage: The TCN Electrode is indicated for use in RF heat… The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with… Class IIFDA’s classApr 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedApr 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Missouri, Nevada, New York, Ohio, Oklahoma, Oregon, South Carolina, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Nitinol Thermocouple Electrode, 15 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for use in RF… The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with… Class IIFDA’s classApr 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedApr 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Missouri, Nevada, New York, Ohio, Oklahoma, Oregon, South Carolina, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Nitinol Thermocouple Electrode, 5cm - Product Usage: The TCN Electrode is indicated for use in RF heat… The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with… Class IIFDA’s classApr 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedApr 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Missouri, Nevada, New York, Ohio, Oklahoma, Oregon, South Carolina, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall STA - Deficient VIII A risk of sample-to-sample cross-contamination of Emicizumab for factor VIII assays on Stago instruments, clotting times will be shortened that may cause… Class IIFDA’s classApr 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Merlin PCS 3650 Software Upgrade Kit Internal testing of software identified software anomaly scenarios where if non-applicable shock energy value is selected, the device will continue to use the… Class IIFDA’s classApr 22, 2020in FDA’s Enforcement Report39 statesnamed in where it went PublishedApr 22, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall SPICE (JWH-018) CC443 Corrections are being made to the device labeling regarding its intended use, to include a statement clarifying it is for research purposes only. Class IIFDA’s classApr 22, 2020in FDA’s Enforcement Report4 statesnamed in where it went PublishedApr 22, 2020ClassClass IIStatusTerminatedWhereAlabama, California, Louisiana and New York
- Medical device recall ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Patient… A nonsterile bulk product designated for further processing in a tray was inadvertently shipped to a customer. Class IIFDA’s classApr 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Illinois named
- Medical device recall The CF-70 instrument (product code: LXG Software mismatch-When the software versions between the SP-50 and CF-70 are not matched, and an error condition occurs requiring the operator to open the… Class IIFDA’s classApr 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedApr 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Utah and Washington named
- Medical device recall Oncomine Dx Target Test DNA Control-IVD for detection of DNA and RNA isolated from non-small cell lung cancer… Extended Expiration Date prior to clearance Class IIFDA’s classApr 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Oncomine Dx Target Test RNA Control- IVD for detection of DNA and RNA isolated from non-small cell lung… Extended Expiration Date prior to clearance Class IIFDA’s classApr 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of DNA and RNA isolated from non-small cell lung… Extended Expiration Date prior to clearance Class IIFDA’s classApr 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ion Torrent Dx No Template Control Kit- IVD for detection of DNA and RNA isolated from non-small cell lung… Extended Expiration Date prior to clearance Class IIFDA’s classApr 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2020ClassClass IIStatusTerminatedWhereNationwide
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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