Medical devices, 2019
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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 IntelliVue MX40 Patient Monitor, Product number 865350, Service # USA: 453564262491 and 453564262511 -… The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State . Class IIFDA’s classJun 12, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IntelliVue MX40 Patient Monitor, Product number 865351, Service Numbers All other countries: 453564451791,… The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State . Class IIFDA’s classJun 12, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IntelliVue MX40 Patient Monitor, Product number 865352, Service Numbers All: 453564262571, 453564262591,… The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State . Class IIFDA’s classJun 12, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IntelliVue MX40 Patient Monitor, Product number 857146, Service Numbers All: 453564711531 and 453564711541 -… The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State . Class IIFDA’s classJun 12, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CyberKnife M6 There is an unintended drop of a secondary collimator housing that can occur during housing Xchange(TM) workflows. Class IIFDA’s classJun 12, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall CyberKnife VSI There is an unintended drop of a secondary collimator housing that can occur during housing Xchange(TM) workflows. Class IIFDA’s classJun 12, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall TLS2 Thermal Ligating Shears The shears exhibited a high rate of complete or intermittent failure to actuate. Class IIFDA’s classJun 12, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereNorth Dakota and New York
- Medical device recall 2008T BlueStar Machine Software v.2.72-Hemodialysis machine Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72. Class IIIFDA’s classJun 12, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG Updated Warning Statements in the Operator’s Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in… Class IIFDA’s classJun 12, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AngioDynamics Solero Microwave Tissue Ablation (MTA) System Updated Warning Statements in the Operator’s Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in… Class IIFDA’s classJun 12, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AngioDynamics Solero Microwave Tissue Ablation (MTA) System Updated Warning Statements in the Operator’s Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in… Class IIFDA’s classJun 12, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AngioDynamics Solero Microwave Tissue Ablation (MTA) System Updated Warning Statements in the Operator’s Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in… Class IIFDA’s classJun 12, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AngioDynamics Solero Microwave Tissue Ablation (MTA) System Updated Warning Statements in the Operator’s Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in… Class IIFDA’s classJun 12, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NxStage PureFlow B Solution Certain lots were mislabeled with incorrect product number. Class IIFDA’s classJun 12, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, District of Columbia, Florida, Georgia, Illinois, Indiana, Michigan, North Carolina, New Hampshire, Nevada, Pennsylvania, Texas and Virginia named
- Medical device recall NxStage PureFlow B Solution Certain lots were mislabeled with incorrect product number. Class IIFDA’s classJun 12, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, District of Columbia, Florida, Georgia, Illinois, Indiana, Michigan, North Carolina, New Hampshire, Nevada, Pennsylvania, Texas and Virginia named
- Medical device recall Stryker Neurovascular, AXS Infinity LS Plus Long Sheath A design related issue can contribute to the device exhibiting brittle behavior. Class IIFDA’s classJun 12, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, 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 Alinity c Cuvette Segments, List Number 04S47-01 Product Usage: The Alinity c Cuvettes are used on the… Individual cuvettes within the Alinity c Cuvette Segment may become seated lower than the designed height. Class IIFDA’s classJun 12, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maine, Minnesota, Missouri, New Jersey, New York, Oklahoma, Puerto Rico, South Carolina, Tennessee, Texas, Utah and Virginia named
- Medical device recall BD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System intended for use in the peripheral vascular system Leak from the septum assembly or the canister may burst under high pressure which could result in blood exposure to a health care worker. Class IIFDA’s classJun 12, 2019in FDA’s Enforcement ReportVirginiathe one state its words name PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereVirginia
- Medical device recall Prometra Clinician Programmer (Touchscreen) Software version 2.00.29 The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. Class IIFDA’s classJun 12, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Prometra Programmer (Grand Prime) Software version 2.00.29 The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. Class IIFDA’s classJun 12, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Prometra Programmable Pump The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. Class IIFDA’s classJun 12, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Prometra II Programmable Pump The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. Class IIFDA’s classJun 12, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Prometra II Programmable Pump (Clinical) The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. Class IIFDA’s classJun 12, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBlock Cutting Guide is a… The OMNIBotics iBlock Cutting Guide does not lock onto the iBlock Saw Guide as intended and may loosen during use. Class IIFDA’s classJun 12, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereNationwide, and Oklahoma, South Carolina and Wisconsin named
- Medical device recall Rim Plate, 10-Hole, Left, PRS RX System The titanium implant has the wrong article number laser marked on it. Class IIFDA’s classJun 12, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 12, 2019ClassClass IIStatusOngoingWhereNationwide, and Florida and Puerto Rico named
- Medical device recall Sterile Nail Clipper Concave Edge Compromised seal on the sterile barrier pouch. Class IIFDA’s classJun 12, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sterile Nail Nipper, Barrel Spring (I68400), Sterile Compromised seal on the sterile barrier pouch. Class IIFDA’s classJun 12, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes. Class IIFDA’s classJun 12, 2019in FDA’s Enforcement Report21 statesnamed in where it went PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia and Washington
- Medical device recall Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282 Affected products may have been manufactured with the catheter distal end hole too small Class IIFDA’s classJun 12, 2019in FDA’s Enforcement ReportOhiothe one state its words name PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereOhio
- Medical device recall Pericardiocentesis Catheter Tray, RPN C-PCYS-850, Order # G03284 Affected products may have been manufactured with the catheter distal end hole too small Class IIFDA’s classJun 12, 2019in FDA’s Enforcement ReportOhiothe one state its words name PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereOhio
- Medical device recall Pericardiocentesis Catheter Tray, RPN C-PCSY-850-LHSC-061096, Order # G10030 Affected products may have been manufactured with the catheter distal end hole too small Class IIFDA’s classJun 12, 2019in FDA’s Enforcement ReportOhiothe one state its words name PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereOhio
- Medical device recall Thoracentesis Set, RPN C-THS-850, Order # G03286 Affected products may have been manufactured with the catheter distal end hole too small Class IIFDA’s classJun 12, 2019in FDA’s Enforcement ReportOhiothe one state its words name PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereOhio
- Medical device recall Stryker High Flow II Tube Set The heated tube sets were consistently leaking and detaching from the cassette. Class IIFDA’s classJun 12, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP) The heated tube sets were consistently leaking and detaching from the cassette. Class IIFDA’s classJun 12, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP) The heated tube sets were consistently leaking and detaching from the cassette. Class IIFDA’s classJun 12, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial applications,… The current labelling does not include any specific warning about usage of flammable freezing sprays. Class IIFDA’s classJun 12, 2019in FDA’s Enforcement Report51 statesnamed in where it went PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereAlaska, 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
- Medical device recall Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226 Product Usage: On April 9,… Product with incorrect shelf life. Class IIFDA’s classJun 12, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedJun 12, 2019ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New York, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, West Virginia and Wyoming named
- Medical device recall Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 70845357041233 Product Usage: On April 9,… Product with incorrect shelf life. Class IIFDA’s classJun 12, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedJun 12, 2019ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New York, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, West Virginia and Wyoming named
- Medical device recall Portex Blue Line Ultra Tracheostomy Tube Inner Cannula Packaged with an incorrect size inner cannula. Class IIFDA’s classJun 12, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Connecticut, Florida, Illinois, Kentucky, Massachusetts, Maryland, North Carolina, New Jersey, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Utah and Virginia named
- Medical device recall Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Incorrect needle length and gage. Class IIFDA’s classJun 12, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Indiana, Massachusetts, Minnesota, Missouri, Mississippi, New Jersey, New York, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia and Washington named
- Medical device recall GETINGE MEERA MOBILE OPERATING TABLE User may suffer an electric shock when coming in contact with the exposed electronic components Class IIFDA’s classJun 12, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Lineum 4.35mm x 28mm Translation Screw Etching on the tulip head incorrectly states “24MM” instead of the correct “28MM” marking. Class IIFDA’s classJun 12, 2019in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereCalifornia, North Carolina and New York
- Medical device recall Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion. Class IIFDA’s classJun 12, 2019in FDA’s Enforcement Report7 statesnamed in where it went PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereCalifornia, Indiana, Louisiana, New Mexico, New York, Texas and Wisconsin
- Medical device recall Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion. Class IIFDA’s classJun 12, 2019in FDA’s Enforcement Report7 statesnamed in where it went PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereCalifornia, Indiana, Louisiana, New Mexico, New York, Texas and Wisconsin
- Medical device recall Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion. Class IIFDA’s classJun 12, 2019in FDA’s Enforcement Report7 statesnamed in where it went PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereCalifornia, Indiana, Louisiana, New Mexico, New York, Texas and Wisconsin
- Medical device recall Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion. Class IIFDA’s classJun 12, 2019in FDA’s Enforcement Report7 statesnamed in where it went PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereCalifornia, Indiana, Louisiana, New Mexico, New York, Texas and Wisconsin
- Medical device recall Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion. Class IIFDA’s classJun 12, 2019in FDA’s Enforcement Report7 statesnamed in where it went PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereCalifornia, Indiana, Louisiana, New Mexico, New York, Texas and Wisconsin
- Medical device recall Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion. Class IIFDA’s classJun 12, 2019in FDA’s Enforcement Report7 statesnamed in where it went PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereCalifornia, Indiana, Louisiana, New Mexico, New York, Texas and Wisconsin
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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