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 Berchtold Chromophare F528 Surgical Lights The back cover of the light head was insufficiently assembled and could potentially fall off the light. Class IIFDA’s classSep 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 18, 2019ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Berchtold Chromophare F628 Surgical Lights The back cover of the light head was insufficiently assembled and could potentially fall off the light. Class IIFDA’s classSep 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 18, 2019ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Norm-O-Temp model 111Z The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage. Class IIFDA’s classSep 11, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 11, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Norm-O-Temp model 111W The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage. Class IIFDA’s classSep 11, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 11, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems. Reversed expiration and manufacturing date on the label Class IIFDA’s classSep 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Titan Gel Serum Protein Control: SPE Control Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range. Class IIFDA’s classSep 11, 2019in FDA’s Enforcement Report10 statesnamed in where it went PublishedSep 11, 2019ClassClass IIStatusTerminatedWhereFlorida, Illinois, Minnesota, Montana, New York, Ohio, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures used for clamping and… A small crack at the box lock corner may after multiple cleaning and sterilization cycles produce an increased risk of corrosion, weakening the instrument and… Class IIFDA’s classSep 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F A single batch of Diatech Diamond dental burs, 856-016-7-F, Round end taper, contain diamond burs with the same grit size (fine) and shape (round end taper)… Class IIFDA’s classSep 11, 2019in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedSep 11, 2019ClassClass IIStatusTerminatedWhereGeorgia
- Medical device recall SPECTRALIS with HEYEX2 image management system Error in the default configuration which could lead to the incorrect display of patient master data. Class IIFDA’s classSep 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate Class IIFDA’s classSep 11, 2019in FDA’s Enforcement Report6 statesnamed in where it went PublishedSep 11, 2019ClassClass IIStatusTerminatedWhereIowa, Illinois, Missouri, New York, Ohio and Tennessee
- Medical device recall BD Kiestra InoqulA+ Software Version 20.3 An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate Class IIFDA’s classSep 11, 2019in FDA’s Enforcement Report6 statesnamed in where it went PublishedSep 11, 2019ClassClass IIStatusTerminatedWhereIowa, Illinois, Missouri, New York, Ohio and Tennessee
- Medical device recall syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition… SOMATOM Definition Edge, SOMATOM Definition AS, SOMATOM Definition Flash with software syngo.CT with Software version VA48A_SP5 may result in scanning workflow… Class IIFDA’s classSep 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fujifilm FDR Go Plus mobile X-ray system The graphics driver of the FDR Go PLUS might cause the appearance of a Blue Screen of Death (BSoD) Class IIFDA’s classSep 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore.. Class IIFDA’s classSep 11, 2019in FDA’s Enforcement ReportMinnesotathe one state its words name PublishedSep 11, 2019ClassClass IIStatusTerminatedWhereMinnesota
- Medical device recall Alaris EtCO2 Calibration; it has been determined that the capnographs may have been calibrated during manufacturing using a lower than specified concentration of CO2 Class IIFDA’s classSep 11, 2019in FDA’s Enforcement Report10 statesnamed in where it went PublishedSep 11, 2019ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Iowa, Illinois, Kansas, Kentucky, Minnesota, North Carolina, South Dakota and Texas
- Medical device recall AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .018 PROCEDURE KIT PG The affected product is properly labelled with an expiration date of March 31, 2022; but the RFID programmed expiration date is April-2014 which results in an… Class IIFDA’s classSep 11, 2019in FDA’s Enforcement Report8 statesnamed in where it went PublishedSep 11, 2019ClassClass IIStatusTerminatedWhereDistrict of Columbia, Illinois, Indiana, Michigan, New Jersey, Tennessee, Texas and Wisconsin
- Medical device recall The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay for the quantitative in vitro… The firm conducted internal investigations that confirmed customer complaints of quality control (QC) imprecision and calibration failures for the Tina-quant… Class IIFDA’s classSep 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare… The mounts on the monitor may have an insufficient weld. Class IIFDA’s classSep 11, 2019in FDA’s Enforcement Report21 statesnamed in where it went PublishedSep 11, 2019ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas and Wisconsin
- Medical device recall Flexible Intubation Fiberscope The action is being initiated due to intubation scopes improperly manufactured with a double port luer instead of a single port luer. Class IIFDA’s classSep 11, 2019in FDA’s Enforcement Report9 statesnamed in where it went PublishedSep 11, 2019ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Louisiana, Maine, Missouri, New Mexico, New York, Ohio and Virginia
- Medical device recall The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offered in two… incorrect device size being listed on the impacted device packaging Class IIFDA’s classSep 11, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 11, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SonarMed AirWave Monitor Potential for the presence of two error codes which would make the monitor inoperable. Class IIFDA’s classSep 11, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 11, 2019ClassClass IIStatusTerminatedWhereCalifornia and Texas
- Medical device recall ES1725KFXN ESPOCAN SPINAL/EPID TRY NRFIT The filter capacity is not achieved due to damage of the filter membrane. Class IIFDA’s classSep 11, 2019in FDA’s Enforcement Report10 statesnamed in where it went PublishedSep 11, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Georgia, Illinois, Minnesota, Missouri, North Carolina, Pennsylvania and Texas
- Medical device recall ES1827KN SPINAL/EPIDURAL TRAY NRFIT The filter capacity is not achieved due to damage of the filter membrane. Class IIFDA’s classSep 11, 2019in FDA’s Enforcement Report10 statesnamed in where it went PublishedSep 11, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Georgia, Illinois, Minnesota, Missouri, North Carolina, Pennsylvania and Texas
- Medical device recall FEF 100N FLAT EPIDURAL FILTER NRFIT The filter capacity is not achieved due to damage of the filter membrane. Class IIFDA’s classSep 11, 2019in FDA’s Enforcement Report10 statesnamed in where it went PublishedSep 11, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Georgia, Illinois, Minnesota, Missouri, North Carolina, Pennsylvania and Texas
- Medical device recall CE17TKN CONT EPIDURALTUOHY NRFIT The filter capacity is not achieved due to damage of the filter membrane. Class IIFDA’s classSep 11, 2019in FDA’s Enforcement Report10 statesnamed in where it went PublishedSep 11, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Georgia, Illinois, Minnesota, Missouri, North Carolina, Pennsylvania and Texas
- Medical device recall CE17TKFCN EPID TRAY W/ 17GA TUOHY NRFIT The filter capacity is not achieved due to damage of the filter membrane. Class IIFDA’s classSep 11, 2019in FDA’s Enforcement Report10 statesnamed in where it went PublishedSep 11, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Georgia, Illinois, Minnesota, Missouri, North Carolina, Pennsylvania and Texas
- Medical device recall CE17TKFCSN CON EPI TRAY W/17G TUHY NRFIT The filter capacity is not achieved due to damage of the filter membrane. Class IIFDA’s classSep 11, 2019in FDA’s Enforcement Report10 statesnamed in where it went PublishedSep 11, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Georgia, Illinois, Minnesota, Missouri, North Carolina, Pennsylvania and Texas
- Medical device recall CE18TKN ACCU-BLOC PERIFIX KIT NRFIT The filter capacity is not achieved due to damage of the filter membrane. Class IIFDA’s classSep 11, 2019in FDA’s Enforcement Report10 statesnamed in where it went PublishedSep 11, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Georgia, Illinois, Minnesota, Missouri, North Carolina, Pennsylvania and Texas
- Medical device recall CE18HKN ACCU-BLOC PERIFIX KIT NRFIT The filter capacity is not achieved due to damage of the filter membrane. Class IIFDA’s classSep 11, 2019in FDA’s Enforcement Report10 statesnamed in where it went PublishedSep 11, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Georgia, Illinois, Minnesota, Missouri, North Carolina, Pennsylvania and Texas
- Medical device recall CE18TKSTN CONT EPID W/SOFT TIP NRFIT The filter capacity is not achieved due to damage of the filter membrane. Class IIFDA’s classSep 11, 2019in FDA’s Enforcement Report10 statesnamed in where it went PublishedSep 11, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Georgia, Illinois, Minnesota, Missouri, North Carolina, Pennsylvania and Texas
- Medical device recall Alere Cholestech LDX Analyzer The polarity of the output of power supply was reversed. Class IIFDA’s classSep 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedSep 11, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall cobas e 601 module (cobas 6000 Modular Series system) Quality issue with high pressure solenoid valves may cause inaccurate results. Class IIFDA’s classSep 11, 2019in FDA’s Enforcement Report15 statesnamed in where it went PublishedSep 11, 2019ClassClass IIStatusTerminatedWhereAlaska, California, Florida, Hawaii, Indiana, Kansas, Kentucky, Louisiana, Maryland, Missouri, Montana, New York, Ohio, Oregon and Texas
- Medical device recall Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module Quality issue with high pressure solenoid valves Class IIFDA’s classSep 11, 2019in FDA’s Enforcement Report15 statesnamed in where it went PublishedSep 11, 2019ClassClass IIStatusTerminatedWhereAlaska, California, Florida, Hawaii, Indiana, Kansas, Kentucky, Louisiana, Maryland, Missouri, Montana, New York, Ohio, Oregon and Texas
- Medical device recall cobas c513 Analyzer Quality issue with high pressure solenoid valves Class IIFDA’s classSep 11, 2019in FDA’s Enforcement Report15 statesnamed in where it went PublishedSep 11, 2019ClassClass IIStatusTerminatedWhereAlaska, California, Florida, Hawaii, Indiana, Kansas, Kentucky, Louisiana, Maryland, Missouri, Montana, New York, Ohio, Oregon and Texas
- Medical device recall OMNIlife science, Inc Acetabular liners failed the oxidation testing performed prior to release. Class IIFDA’s classSep 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedSep 11, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Colorado, Florida, Illinois, Maryland, New York, Oklahoma, Pennsylvania and Utah named
- Medical device recall OMNIlife science, Inc Acetabular liners failed the oxidation testing performed prior to release. Class IIFDA’s classSep 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedSep 11, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Colorado, Florida, Illinois, Maryland, New York, Oklahoma, Pennsylvania and Utah named
- Medical device recall OMNIlife science, Inc Acetabular liners failed the oxidation testing performed prior to release. Class IIFDA’s classSep 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedSep 11, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Colorado, Florida, Illinois, Maryland, New York, Oklahoma, Pennsylvania and Utah named
- Medical device recall HS Hi-R NEO 900 Reference # 657 820 Serial # from 101 Product Usage: A wide range of surgical interventions… software error in the central control unit of the floor stand. Class IIFDA’s classSep 11, 2019in FDA’s Enforcement ReportOhiothe one state its words name PublishedSep 11, 2019ClassClass IIStatusTerminatedWhereOhio
- Medical device recall HS Hi-R NEO 900A Reference # 657 821 Serial # from 101 Product Usage: A wide range of surgical interventions… software error in the central control unit of the floor stand. Class IIFDA’s classSep 11, 2019in FDA’s Enforcement ReportOhiothe one state its words name PublishedSep 11, 2019ClassClass IIStatusTerminatedWhereOhio
- Medical device recall HS Hi-R NEO 900A NIR Reference # 657 822 Serial # from 101 Product Usage: A wide range of surgical… software error in the central control unit of the floor stand. Class IIFDA’s classSep 11, 2019in FDA’s Enforcement ReportOhiothe one state its words name PublishedSep 11, 2019ClassClass IIStatusTerminatedWhereOhio
- Medical device recall Quantum Pump Console Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 4, 2019in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 4, 2019ClassClass IStatusTerminatedWhereNew York, Ohio, Virginia and Washington
- Medical device recall Medline SYRINGE, PISTON,IRR TRAY,W/.9 Samples in the identified lot were found to have incomplete or open packaging seals. Class IIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MassHunter Quantitative Analysis Software, Version B.07.01, used with Triple Quadrupole Mass Spectrometers,… When utilizing specific software versions of an LC/MS device, and Batch at a Glance in Compound Table view, a defect occurs when a new sample(s) is inserted. Class IIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow… The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. Class IIFDA’s classSep 4, 2019in FDA’s Enforcement Report6 statesnamed in where it went PublishedSep 4, 2019ClassClass IIStatusTerminatedWhereArizona, California, Florida, Massachusetts, Michigan and Puerto Rico
- Medical device recall Roche Elecsys Anti-CCP Immunoassay Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; MODULAR ANALYTICS E 170 module; and cobas e 601, 602, and 801… Class IIFDA’s classSep 4, 2019in FDA’s Enforcement Report22 statesnamed in where it went PublishedSep 4, 2019ClassClass IIStatusTerminatedWhereArizona, California, Florida, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Montana, New Jersey, New York, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Texas and Virginia
- Medical device recall Roche Elecsys Anti-CCP Immunoassay Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; MODULAR ANALYTICS E 170 module; and cobas e 601, 602, and 801… Class IIFDA’s classSep 4, 2019in FDA’s Enforcement Report22 statesnamed in where it went PublishedSep 4, 2019ClassClass IIStatusTerminatedWhereArizona, California, Florida, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Montana, New Jersey, New York, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Texas and Virginia
- Medical device recall Alinity ci -series System Control¿Module Abbott has identified an issue with all on market versions (v2.6.0 and v2.6.1) of Alinity ci series Software where incorrect results may occur after a system… Class IIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TransWarmer Warming Infant Transport Mattress The firm updated the IFU in April 2019 to clarify that use of the TRANSWARMER Mattress with other heat producing devices, such as an incubator, is prohibited… Class IIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2019ClassClass 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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