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 Endotrac ECTR Push Blade The seal integrity of the sterile bag containing the kits may be compromised. Class IIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Endotrac ECTR Triangle Blade The seal integrity of the sterile bag containing the kits may be compromised. Class IIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Endotrac ECTR Hook Blade The seal integrity of the sterile bag containing the kits may be compromised. Class IIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Endotrac EPF/EGR Push Blade The seal integrity of the sterile bag containing the kits may be compromised. Class IIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Endotrac EPF/EGR Triangle Blade The seal integrity of the sterile bag containing the kits may be compromised. Class IIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Endotrac EPF/EGR Hook Blade The seal integrity of the sterile bag containing the kits may be compromised. Class IIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Endintrak 2 Hook Blade The seal integrity of the sterile bag containing the kits may be compromised. Class IIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Endotrac ECTR Triangle Blade, Angled The seal integrity of the sterile bag containing the kits may be compromised. Class IIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Endotrac ECTR Hook Blade, Angled The seal integrity of the sterile bag containing the kits may be compromised. Class IIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Endotrac EPF/EGR Triangle Blade, Angled The seal integrity of the sterile bag containing the kits may be compromised. Class IIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Endotrac EPF/EGR Hook Blade, Angled The seal integrity of the sterile bag containing the kits may be compromised. Class IIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Endintrak¿ 2 Hook Blade, Angled The seal integrity of the sterile bag containing the kits may be compromised. Class IIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM The action is being initiated due to Flexible Neuroscopes manufactured with the incorrect channel port. Class IIFDA’s classSep 4, 2019in FDA’s Enforcement Report13 statesnamed in where it went PublishedSep 4, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Massachusetts, Michigan, Missouri, North Carolina, New Hampshire, Ohio, Oregon, Pennsylvania, Virginia and Washington
- Medical device recall EXACTAMED Oral Dispensers, 5mL, AMBER: PHARMACY PACK EXACTAMED 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 10 mL oral dispensers. Class IIIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) The action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 28, 2019in FDA’s Enforcement Report12 statesnamed in where it went PublishedAug 28, 2019ClassClass IStatusTerminatedWhereAlabama, California, Georgia, Kansas, Massachusetts, Maryland, Minnesota, New York, Oregon, Tennessee, Virginia and Washington
- Medical device recall Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) The action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 28, 2019in FDA’s Enforcement Report12 statesnamed in where it went PublishedAug 28, 2019ClassClass IStatusTerminatedWhereAlabama, California, Georgia, Kansas, Massachusetts, Maryland, Minnesota, New York, Oregon, Tennessee, Virginia and Washington
- Medical device recall Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) The action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 28, 2019in FDA’s Enforcement Report12 statesnamed in where it went PublishedAug 28, 2019ClassClass IStatusTerminatedWhereAlabama, California, Georgia, Kansas, Massachusetts, Maryland, Minnesota, New York, Oregon, Tennessee, Virginia and Washington
- Medical device recall Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) The action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 28, 2019in FDA’s Enforcement Report12 statesnamed in where it went PublishedAug 28, 2019ClassClass IStatusTerminatedWhereAlabama, California, Georgia, Kansas, Massachusetts, Maryland, Minnesota, New York, Oregon, Tennessee, Virginia and Washington
- Medical device recall IMMULITE 1000 Progesterone There is a potential for low discordant progesterone results on a subset of patient samples. Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IMMULITE 2000 Progesterone There is a potential for low discordant progesterone results on a subset of patient samples. Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MICRO-TEMP LT System Updated Manual-Warnigs have been added stating that exceeding 40’C for extended periods may cause tissue damage Class IIIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Luminex Aries M1 System An incorrect control board and firmware installed in some of the Hand Held Barcode Scanners could result in sample/patient mismatch or duplicate results (from… Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DeRoyal Enteral Safe Feeding Tubes: a) Certain MED-RX Polyurethane Feeding Tubes are being recalled due to a product concern where the connector has detached from the feeding tube. Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Illinois, Kentucky, New Mexico, Ohio, Texas and Utah named
- Medical device recall TiLite X-Short anti-tip tubes, models TRA, AERO T, ZRA, AERO Z, 2GX, AERO X, Twist, and AERO R, a component… The anti-tip tubes potentially fail in certain situations and the wheelchairs can tip backwards. Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Brand Name Burn Navigator¿ Battery packs may heat up abnormally and ignite in rare instance. Class IIFDA’s classAug 28, 2019in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereArizona, Louisiana, Maryland, Oregon, Texas and Washington
- Medical device recall BD Vacutainer Lithium HeparinN (LH) 37 USP Units Blood Collection Tubes False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000… Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Vacutainer Lithium HeparinN (LH) 56 USP Units Blood Collection Tubes False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000… Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Vacutainer Lithium HeparinN (LH) 158 USP Units Blood Collection Tubes False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000… Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Vacutainer Lithium HeparinN 75 USP Units Blood Collection Tubes False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000… Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Vacutainer Lithium HeparinN (LH) 95 USP Units Blood Collection Tubes False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000… Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000… Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Vacutainer PST Gel and Lithium HeparinN (LH) 65 Units Blood Collection Tubes False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000… Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Vacutainer PST Gel and Lithium HeparinN (LH) 83 Units Blood Collection Tubes False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000… Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Vacutainer PST Gel and Lithium HeparinN (LH) Blood Collection Tubes False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000… Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Vacutainer PST Gel and Lithium HeparinN (LH) 126 Units Blood Collection Tubes False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000… Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Vacutainer PST Blood Collection Tubes False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000… Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000… Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Vacutainer LH (Lithium Heparin) 34 I.U False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000… Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Vacutainer LH (Lithium Heparin) 68 I.U False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000… Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Vacutainer LH (Lithium Heparin) 102 I.U False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000… Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsymphony SP instrument is… QIAsymphony software version 5.0.3 - Software issue incorreclty assigns the 2D bar code eluate ID to the sample within the results file. Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ABL90 FLEX Analyzer Software Security; The action is being initiated because of software security vulnerabilities with the firm’s analyzer operating system, which may cause the… Class IIFDA’s classAug 28, 2019in FDA’s Enforcement Report36 statesnamed in where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Kit BD Max Check-Points CPO IVD EU The foil bags containing extraction tubes for BD MAX” Reagent products may not been sealed properly. Class IIFDA’s classAug 28, 2019in FDA’s Enforcement Report38 statesnamed in where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Kit BD Max Cdiff EU The foil bags containing extraction tubes for BD MAX” Reagent products may not been sealed properly. Class IIFDA’s classAug 28, 2019in FDA’s Enforcement Report38 statesnamed in where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Kit BD Max ExK DNA 1 USA The foil bags containing extraction tubes for BD MAX” Reagent products may not been sealed properly. Class IIFDA’s classAug 28, 2019in FDA’s Enforcement Report38 statesnamed in where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Kit BD Max ExK DNA 1 EU LUO The foil bags containing extraction tubes for BD MAX” Reagent products may not been sealed properly. Class IIFDA’s classAug 28, 2019in FDA’s Enforcement Report38 statesnamed in where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Kit BD Max ExK DNA 2 USA The foil bags containing extraction tubes for BD MAX” Reagent products may not been sealed properly. Class IIFDA’s classAug 28, 2019in FDA’s Enforcement Report38 statesnamed in where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Kit BD Max ExK DNA 2 EU LUO The foil bags containing extraction tubes for BD MAX” Reagent products may not been sealed properly. Class IIFDA’s classAug 28, 2019in FDA’s Enforcement Report38 statesnamed in where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
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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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