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 7, 2026.
3,055of 3,055 medical device recallsshown with your filters
The list
- Medical device recall Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources,… Centricity Universal Viewer measurements saved into a DICOM Grayscale Presentation State are incorrect in subsequent views for exams containing series with… Class IIFDA’s classJan 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Koios DS Breast <series 1.0> Affected software product versions were found during internal audit to have been marketed for sale without sufficient documentation pertaining to certain… Class IIFDA’s classJan 29, 2020in FDA’s Enforcement Report3 statesnamed in where it went PublishedJan 29, 2020ClassClass IIStatusTerminatedWhereMissouri, New Jersey and New York
- Medical device recall Acidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson Centrifugal Pump There is a potential for an uneven plastic encapsulation of the magnet ring during the molding process and partial axial displacement. Class IIFDA’s classJan 29, 2020in FDA’s Enforcement Report13 statesnamed in where it went PublishedJan 29, 2020ClassClass IIStatusTerminatedWhereAlabama, Florida, Georgia, Massachusetts, Maryland, Minnesota, North Carolina, New Mexico, New York, Ohio, Oklahoma, Texas and Virginia
- Medical device recall Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump There is a potential for an uneven plastic encapsulation of the magnet ring during the molding process and partial axial displacement. Class IIFDA’s classJan 29, 2020in FDA’s Enforcement Report13 statesnamed in where it went PublishedJan 29, 2020ClassClass IIStatusTerminatedWhereAlabama, Florida, Georgia, Massachusetts, Maryland, Minnesota, North Carolina, New Mexico, New York, Ohio, Oklahoma, Texas and Virginia
- Medical device recall Finish Thompson Centrifugal Pump There is a potential for an uneven plastic encapsulation of the magnet ring during the molding process and partial axial displacement. Class IIFDA’s classJan 29, 2020in FDA’s Enforcement Report13 statesnamed in where it went PublishedJan 29, 2020ClassClass IIStatusTerminatedWhereAlabama, Florida, Georgia, Massachusetts, Maryland, Minnesota, North Carolina, New Mexico, New York, Ohio, Oklahoma, Texas and Virginia
- Medical device recall TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system. Class IIFDA’s classJan 29, 2020in FDA’s Enforcement Report6 statesnamed in where it went PublishedJan 29, 2020ClassClass IIStatusTerminatedWhereCalifornia, Illinois, Nebraska, New York, Ohio and Wisconsin
- Medical device recall TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system. Class IIFDA’s classJan 29, 2020in FDA’s Enforcement Report6 statesnamed in where it went PublishedJan 29, 2020ClassClass IIStatusTerminatedWhereCalifornia, Illinois, Nebraska, New York, Ohio and Wisconsin
- Medical device recall TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system. Class IIFDA’s classJan 29, 2020in FDA’s Enforcement Report6 statesnamed in where it went PublishedJan 29, 2020ClassClass IIStatusTerminatedWhereCalifornia, Illinois, Nebraska, New York, Ohio and Wisconsin
- Medical device recall Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A06010130 Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded Class IIFDA’s classJan 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product reference: A06010140 Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded Class IIFDA’s classJan 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells SMN:10310308 Homocysteine Assay May Cause Elevated Results in the Folate Assay Class IIFDA’s classJan 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens ADVIA Centaur Folate Homocysteine Assay May Cause Elevated Results in the Folate Assay Class IIFDA’s classJan 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens ADVIA Centaur Folate Homocysteine Assay May Cause Elevated Results in the Folate Assay Class IIFDA’s classJan 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Reference… One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the… Class IIFDA’s classJan 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, without box or carrying case,… One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the… Class IIFDA’s classJan 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036 One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the… Class IIFDA’s classJan 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, Reference Number… One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the… Class IIFDA’s classJan 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm Some of the implants were packaged with a Standard Platform Cover Screw instead of a Narrow Platform Cover Screw. Class IIFDA’s classJan 29, 2020in FDA’s Enforcement Report11 statesnamed in where it went PublishedJan 29, 2020ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Florida, Georgia, Massachusetts, Maryland, New Jersey, New York, South Carolina, Texas and Virginia
- Medical device recall Arrow Endurance” Extended Dwell Peripheral Catheter System Potential sterility issue for specific lots of the Arrow Endurance” Extended Dwell Peripheral Catheter System, Product Code ASK-00820-FLH. Class IIFDA’s classJan 29, 2020in FDA’s Enforcement ReportFloridathe one state its words name PublishedJan 29, 2020ClassClass IIStatusTerminatedWhereFlorida
- Medical device recall Imactis Navigation Kit The firm has become aware that the sensor cover, a component of the single-use navigation kit may contain microbial contamination. Class IIFDA’s classJan 29, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 29, 2020ClassClass IIStatusOngoingWhereIllinois and Wisconsin
- Medical device recall Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 systems may result in short circuiting which… Class IIFDA’s classJan 29, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 29, 2020ClassClass IIStatusTerminatedWherePennsylvania and Wisconsin
- Medical device recall Gendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 systems may result in short circuiting which… Class IIFDA’s classJan 29, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 29, 2020ClassClass IIStatusTerminatedWherePennsylvania and Wisconsin
- Medical device recall KaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 systems may result in short circuiting which… Class IIFDA’s classJan 29, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 29, 2020ClassClass IIStatusTerminatedWherePennsylvania and Wisconsin
- Medical device recall Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 systems may result in short circuiting which… Class IIFDA’s classJan 29, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 29, 2020ClassClass IIStatusTerminatedWherePennsylvania and Wisconsin
- Medical device recall iChem VELOCITY Urine Chemistry Analyzer Beckman Coulter has become aware of an issue affecting Specific Gravity chemistry settings for the iChemVELOCITY Urine Chemistry System that prevents the… Class IIFDA’s classJan 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 29, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Arrow Arterial Catherization Kit-20 Ga The lidstock label incorrectly displays a MR (Magnetic Resonance ) Conditional symbol (instead of a MR Unsafe symbol) in reference to a component of the kit Class IIFDA’s classJan 29, 2020in FDA’s Enforcement ReportSouth Carolinathe one state its words name PublishedJan 29, 2020ClassClass IIStatusOngoingWhereSouth Carolina
- Medical device recall CARESCAPE Respiratory Module E-sCO Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 22, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 22, 2020ClassClass IStatusTerminatedWhereNo state named
- Medical device recall CARESCAPE Respiratory Module E-sCOVX Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 22, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 22, 2020ClassClass IStatusTerminatedWhereNo state named
- Medical device recall CARESCAPE Respiratory Module E-sCAiO Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 22, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 22, 2020ClassClass IStatusTerminatedWhereNo state named
- Medical device recall CARESCAPE Respiratory Module E-sCAiOV Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 22, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 22, 2020ClassClass IStatusTerminatedWhereNo state named
- Medical device recall CARESCAPE Respiratory Module E-sCAiOE Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 22, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 22, 2020ClassClass IStatusTerminatedWhereNo state named
- Medical device recall CARESCAPE Respiratory Module E-sCAiOVE Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 22, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 22, 2020ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Airway Gas Option N-CAiO Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 22, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 22, 2020ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Riverpoint Medical 18G Brachy Grid, B&K style The integrity of the sterile grid packaging is potentially compromised. Class IIFDA’s classJan 22, 2020in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 22, 2020ClassClass IIStatusTerminatedWhereFlorida, Illinois, Texas and Washington
- Medical device recall Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape The device label incorrectly states that the device is sterile. Class IIIFDA’s classJan 22, 2020in FDA’s Enforcement Report11 statesnamed in where it went PublishedJan 22, 2020ClassClass IIIStatusTerminatedWhereFlorida, Georgia, Illinois, Massachusetts, Maine, Missouri, North Carolina, New Jersey, Ohio, Texas and Washington
- Medical device recall Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape The device label incorrectly states that the device is sterile. Class IIIFDA’s classJan 22, 2020in FDA’s Enforcement Report11 statesnamed in where it went PublishedJan 22, 2020ClassClass IIIStatusTerminatedWhereFlorida, Georgia, Illinois, Massachusetts, Maine, Missouri, North Carolina, New Jersey, Ohio, Texas and Washington
- Medical device recall ADVANCED ENDOSEE System CANNULA, Cooper Surgical Potential for unsealed pouches in two (2) lots of the Endosee Advance Cannula (P/N: ESPX5). Class IIFDA’s classJan 22, 2020in FDA’s Enforcement Report43 statesnamed in where it went PublishedJan 22, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Gridlock Ankle Screw Driver Bit A screwdriver used to facilitate implant insertion and removal was found to be out of specification for the minor diameter of the drive feature causing the… Class IIFDA’s classJan 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJan 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Connecticut, Iowa, Texas and Wisconsin named
- Medical device recall QuickDraw Venous Cannula If the venous cannula is used in an unintended manner (longer than 6 hours; particularly during extracorporeal membrane oxygenation [ECMO]) there is a risk… Class IIFDA’s classJan 22, 2020in FDA’s Enforcement Report41 statesnamed in where it went PublishedJan 22, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall BriteBlade Pro Single-Use Fiber Optic Mac 3, CE01120, Do Not Re-use The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device. Class IIFDA’s classJan 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BriteBlade Pro Single-se Fiber Optic Miller 2, CE 0120, Do not Re-use The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device. Class IIFDA’s classJan 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3, CE 0120, Do not Re-use The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device. Class IIFDA’s classJan 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device. Class IIFDA’s classJan 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator… Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US.. Class IIFDA’s classJan 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJan 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut and Michigan named
- Medical device recall Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended to… Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm. Class IIFDA’s classJan 22, 2020in FDA’s Enforcement ReportIowathe one state its words name PublishedJan 22, 2020ClassClass IIStatusTerminatedWhereIowa
- Medical device recall Siemens ARTIS pheno The potential exists for system movement to be permanently blocked by an activation of the collision sensor integrated in the cover of the collimator even when… Class IIFDA’s classJan 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJan 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida, Illinois, Indiana, Massachusetts, Pennsylvania and Virginia named
- Medical device recall Merlin PCS Programmer software Devices inappropriately displayed a low battery indicator determined to be due to memory corruption. Class IIFDA’s classJan 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Temperature deviation did not meet release specifications Class IIFDA’s classJan 22, 2020in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedJan 22, 2020ClassClass IIStatusTerminatedWhereIllinois
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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