Medical devices, 2015
Shortlist up to four to read them side by side.
2,495 medical device recalls FDA’s Enforcement Report published in 2015, 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.
2,495of 2,495 medical device recallsshown with your filters
The list
- Medical device recall Philips Multi Diagnost Eleva II The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of the value for the normal mode, but will be approximately… Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Kansas, Kentucky, Louisiana, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia, Vermont, Washington, West Virginia and Wyoming named
- Medical device recall Philips Multi Diagnost Eleva with FlatDetector The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of the value for the normal mode, but will be approximately… Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Kansas, Kentucky, Louisiana, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia, Vermont, Washington, West Virginia and Wyoming named
- Medical device recall The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today’s evolving… One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume levels. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 4, 2015in FDA’s Enforcement Report50 statesnamed in where it went PublishedMar 4, 2015ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today’s evolving… One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume levels. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 4, 2015in FDA’s Enforcement Report50 statesnamed in where it went PublishedMar 4, 2015ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today’s evolving… One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume levels. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 4, 2015in FDA’s Enforcement Report50 statesnamed in where it went PublishedMar 4, 2015ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today’s evolving… One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume levels. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 4, 2015in FDA’s Enforcement Report50 statesnamed in where it went PublishedMar 4, 2015ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today’s evolving… One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume levels. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 4, 2015in FDA’s Enforcement Report50 statesnamed in where it went PublishedMar 4, 2015ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use as a bridge-to-cardiac… The affected clinical trial Controllers exhibit a higher susceptibility to ESD than newer commercial Controllers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedMar 4, 2015ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New York, Ohio, Oregon, Pennsylvania, Texas, Utah, Virginia and Washington named
- Medical device recall CoCr Femoral Head - A modular head component is used in conjunction with a femoral stem component for… Potential compromise of the inner sterile tray. Class IIFDA’s classMar 4, 2015in FDA’s Enforcement Report45 statesnamed in where it went PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Metasul Femoral Head - A modular head component is used in conjunction with a femoral stem component for… Potential compromise of the inner sterile tray. Class IIFDA’s classMar 4, 2015in FDA’s Enforcement Report45 statesnamed in where it went PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Biolox Delta Femoral Head - The BIOLOX delta Ceramic Femoral Head is used in conjunction with compatible… Potential compromise of the inner sterile tray. Class IIFDA’s classMar 4, 2015in FDA’s Enforcement Report45 statesnamed in where it went PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall CoCr Femoral Head - indicated for hip arthroplasty for noncemented use in skeletally mature invididuals… Potential compromise of the inner sterile tray. Class IIFDA’s classMar 4, 2015in FDA’s Enforcement Report45 statesnamed in where it went PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Metasul Femoral Head - indicated for total hip arthroplasty for treatment of patient conditions of… Potential compromise of the inner sterile tray. Class IIFDA’s classMar 4, 2015in FDA’s Enforcement Report45 statesnamed in where it went PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall TDX Electric Wheelchair If the slack in the wires is not routed and secured correctly, flexing of the back pan under the users weight may cause the headrest knob or clamp bracket to… Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall FDX Electric Wheelchair If the slack in the wires is not routed and secured correctly, flexing of the back pan under the users weight may cause the headrest knob or clamp bracket to… Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Storm Series Electric Wheelchair If the slack in the wires is not routed and secured correctly, flexing of the back pan under the users weight may cause the headrest knob or clamp bracket to… Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) Power supply malfunction complaints related to suboptimal thermal management. Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EndoWrist One Vessel Sealer, IS3000, 6 pack used in conjunction with the da Vinci Surgical System Si IS3000… Intuitive Surgical has identified the potential for a certain, small portion of Vessel Sealers to exhibit interference in the back of the instrument grips due… Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EndoWrist One Vessel Sealer, 8MM, IS4000, 6 pack used in conjunction with the da Vinci Surgical System Xi… Intuitive Surgical has identified the potential for a certain, small portion of Vessel Sealers to exhibit interference in the back of the instrument grips due… Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Starburst MRI Semi-Flex Electrode Device, 25cm/Attached Cable/14Ga/6.4F, Product No Printed mark on the trocar intended to indicate a 5cm distance from the distal tip of the needle is actually located 4cm from the distal tip of the needle. Class IIFDA’s classMar 4, 2015in FDA’s Enforcement Report11 statesnamed in where it went PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereArkansas, Arizona, Florida, Michigan, Minnesota, Missouri, New York, Texas, Virginia, Washington and Wisconsin
- Medical device recall Spacelabs Healthcare XPREZZON Bedside Monitor Spacelabs Healthcare XPREZZON Bedside Monitors, Model 91393, are recalled because the firm has received multiple reports of XPREZZON monitors failing to boot… Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Spacelabs Healthcare qube Compact Monitor Spacelabs Healthcare qube Bedside Monitors, Model 91390, are recalled because the firm has received multiple reports of qube monitors failing to boot up or… Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Set Screw 5.5 mm Rod Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specification Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, Nebraska, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall The Medtronic, Quadripolar ITREL 3 IPG Current labeling indicates that cycling improves device longevity in every programming scenario. Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496001001111, REF/Catalog No. 600100111, STERILE The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NAMIC Convenience Kit, 5 VALVE MANIFOLD KIT, UPN H749600105121, REF/Catalog No. 60010512, STERILE The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NAMIC Convenience Kit, NEURO ANGIO KIT, UPN H749600202361, REF/Catalog No. 60020236, STERILE The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NAMIC Convenience Kit, UPN H749600203741, REF/Catalog No. 60020374, STERILE The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600309351, REF/Catalog No. 60030935, STERILE The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NAMIC Convenience Kit, UPN H749600329421, REF/Catalog No. 60032942, STERILE The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NAMIC Convenience Kit, 3 VALVE KIT CARDIOVASCULAR PROCEDURE KIT, UPN H749600403131, REF/Catalog No. 60040313,… The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600407061, REF/Catalog No. 60040706, STERILE The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NAMIC Convenience Kit, 3 VALVE MANIFOLD KIT, UPN H749600411611, REF/Catalog No. 60041161, STERILE The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NAMIC Convenience Kit, MOBILE CATH LAB KIT, UPN H749600419211, REF/Catalog No. 60041921, STERILE The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496005001131, REF/Catalog No. 600500113, STERILE The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NAMIC Convenience Kit, UPN H7496005216131, REF/Catalog No. 600521613, STERILE The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NAMIC Convenience Kit, LEFT HEART, UPN H7496006044121, REF/Catalog No. 600604412, STERILE The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749600617521, REF/Catalog No. 60061752, STERILE The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600618011, REF/Catalog No. 60061801, STERILE The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496007057101, REF/Catalog No. 600705710, STERILE The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NAMIC Convenience Kit, 3 VALVE KIT, UPN H749600709971, REF/Catalog No. 60070997, STERILE The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NAMIC Convenience Kit, LEFT/RIGHT HEART KIT, UPN H7496008010201, REF/Catalog No. 600801020, STERILE The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NAMIC Convenience Kit, LEFT HEART CATH KIT, UPN H7496010018151, REF/Catalog No. 601001815, STERILE The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749601014911, REF/Catalog No. 60101491, STERILE The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601113111, REF/Catalog No. 60111311, STERILE The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NAMIC Convenience Kit, UPN H749601308341, REF/Catalog No. 60130834, STERILE The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NAMIC Convenience Kit, UPN H749601314811, REF/Catalog No. 60131481, STERILE The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NAMIC Convenience Kit, UPN H7496013148131, REF/Catalog No. 601314813, STERILE The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNationwide
Nothing matches all of these.
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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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