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 Go-EZ Screw 6.5x30 Manufacturing flaw in the sterile barrier system Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Louisiana, Maryland, North Carolina, New York, Oregon and Texas named
- Medical device recall Go-EZ Screw 6.5x100 Manufacturing flaw in the sterile barrier system Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Louisiana, Maryland, North Carolina, New York, Oregon and Texas named
- Medical device recall Go-EZ Screw 6.5x36 Manufacturing flaw in the sterile barrier system Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Louisiana, Maryland, North Carolina, New York, Oregon and Texas named
- Medical device recall Go-EZ Screw 6.5x95 Manufacturing flaw in the sterile barrier system Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Louisiana, Maryland, North Carolina, New York, Oregon and Texas named
- Medical device recall Go-EZ Screw 6.5x34 Manufacturing flaw in the sterile barrier system Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Louisiana, Maryland, North Carolina, New York, Oregon and Texas named
- Medical device recall Go-EZ Screw 6.5x85 Manufacturing flaw in the sterile barrier system Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Louisiana, Maryland, North Carolina, New York, Oregon and Texas named
- Medical device recall Go-EZ Screw 6.5x90 Manufacturing flaw in the sterile barrier system Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Louisiana, Maryland, North Carolina, New York, Oregon and Texas named
- Medical device recall Go-EZ Screw 6.5x115 Manufacturing flaw in the sterile barrier system Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Louisiana, Maryland, North Carolina, New York, Oregon and Texas named
- Medical device recall Go-EZ Screw 6.5x32 Manufacturing flaw in the sterile barrier system Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Louisiana, Maryland, North Carolina, New York, Oregon and Texas named
- Medical device recall Go-EZ Screw 6.5x105 Manufacturing flaw in the sterile barrier system Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Louisiana, Maryland, North Carolina, New York, Oregon and Texas named
- Medical device recall Go-EZ Screw 6.5x110 Manufacturing flaw in the sterile barrier system Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Louisiana, Maryland, North Carolina, New York, Oregon and Texas named
- Medical device recall Go-EZ Screw 6.5x120 Manufacturing flaw in the sterile barrier system Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Louisiana, Maryland, North Carolina, New York, Oregon and Texas named
- Medical device recall Go-EZ Screw 6.5x38 Manufacturing flaw in the sterile barrier system Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Louisiana, Maryland, North Carolina, New York, Oregon and Texas named
- Medical device recall K-Wire HBS Sterile Manufacturing flaw in the sterile barrier system Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Louisiana, Maryland, North Carolina, New York, Oregon and Texas named
- Medical device recall Cardinal Health Jackson-Pratt Channel Drain 15FR Cardinal PN:JP-2223 An introduction/drainage catheter is a… 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes Cardinal Health PN: JP-2188 An… 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes, with trocar Product Number: JP-2189 An… 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes Cardinal Health: PN JP-2190 An… 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes, with trocar Cardinal Health: PN: JP-2191 An… 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cardinal Health Jackson-Pratt Channel Drain 19FR, 3/4 flutes, with trocar Cardinal Health: PN JP-2225 An… 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medline Silicone Drain 15Fr 3/16” Full Fluted PN: DYNJWE2188HB An introduction/drainage catheter is a device… 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Smith & Nephew Negative Pressure Wound Therapy 15FR Channel Wound Drain PN: 02872 An introduction/drainage… 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SOMATOM Definition AS Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort. Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SOMATOM Definition Edge Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort. Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SOMATOM Definition Flash Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort. Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SOMATOM Drive Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort. Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SOMATOM Confidence Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort. Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SOMATOM Edge Plus Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort. Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SOMATOM Force Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort. Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall HS70A Diagnostic Ultrasound System Version 2.01.00, 2.01.01, 2.01.02, 2.01.03, 2.01.04, 2.01.05, 2.01.06,… There is a potential for probes overheating when decreasing the Doppler SV (Sample Volume) size value set by the user in the Doppler Only mode. Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall WS80A Diagnostic Ultrasound System Version 1.00.16, 3.00.17, 3.00.18, 3.00.19, 3.01.00, 3.01.01, 3.01.02,… There is a potential for probes overheating when decreasing the Doppler SV (Sample Volume) size value set by the user in the Doppler Only mode. Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box of 20 Product is mislabeled. Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System Handle could jam with the Driver due to the detachment of an internal Connector Ring. Class IIFDA’s classAug 21, 2019in FDA’s Enforcement Report8 statesnamed in where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereCalifornia, Delaware, Florida, Illinois, North Carolina, Nebraska, New York and Tennessee
- Medical device recall BD Vacutainer Fluoride Tubes for Blood Alcohol determinations Lot has been confirmed to have no additive within the tube. Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Missouri, Pennsylvania, Rhode Island and Tennessee named
- Medical device recall GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 Incorrect coil length on the label Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall MED-RX POLYURETHANE FEEDING TUBES: a) 5Fr X 16” The firm received a complaint that the connector detached from the feeding tube. Class IIFDA’s classAug 21, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereGeorgia and Tennessee
- Medical device recall Aries Bordetella Assay Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification,… Class IIFDA’s classAug 21, 2019in FDA’s Enforcement Report34 statesnamed in where it went PublishedAug 21, 2019ClassClass IIStatusOngoingWhereAlaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin
- Medical device recall ARIES HSV 1&2 Assay Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification,… Class IIFDA’s classAug 21, 2019in FDA’s Enforcement Report34 statesnamed in where it went PublishedAug 21, 2019ClassClass IIStatusOngoingWhereAlaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin
- Medical device recall ARIES Flu A/B & RSV Assay Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification,… Class IIFDA’s classAug 21, 2019in FDA’s Enforcement Report34 statesnamed in where it went PublishedAug 21, 2019ClassClass IIStatusOngoingWhereAlaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin
- Medical device recall ARIES GBS Assay Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification,… Class IIFDA’s classAug 21, 2019in FDA’s Enforcement Report34 statesnamed in where it went PublishedAug 21, 2019ClassClass IIStatusOngoingWhereAlaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin
- Medical device recall ARIES Group A Strep Assay Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification,… Class IIFDA’s classAug 21, 2019in FDA’s Enforcement Report34 statesnamed in where it went PublishedAug 21, 2019ClassClass IIStatusOngoingWhereAlaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin
- Medical device recall ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059 Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification,… Class IIFDA’s classAug 21, 2019in FDA’s Enforcement Report34 statesnamed in where it went PublishedAug 21, 2019ClassClass IIStatusOngoingWhereAlaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin
- Medical device recall ARIES Extraction Kit Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification,… Class IIFDA’s classAug 21, 2019in FDA’s Enforcement Report34 statesnamed in where it went PublishedAug 21, 2019ClassClass IIStatusOngoingWhereAlaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin
- Medical device recall ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs) Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs) Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall ELLIPSE VR, Tiered-therapy cardioverter/defibrillator Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs) Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall ELLIPSE DR, Tiered-therapy cardioverter/defibrillator Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2019ClassClass IStatusTerminatedWhereNationwide
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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