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 NAMIC Convenience Kit, ANGIO KIT, UPN H749601319961, REF/Catalog No. 60131996, 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, DYE CATH LAB KIT, UPN H749601367131, REF/Catalog No. 60136713, 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 H749601399921, REF/Catalog No. 60139992, 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 H749601506721, REF/Catalog No. 60150672, 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 H749601506921, REF/Catalog No. 60150692, 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 H7496016046121, REF/Catalog No. 601604612, 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 H749601605351, REF/Catalog No. 60160535, 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 H749601617931, REF/Catalog No. 60161793, 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 H749601801561, REF/Catalog No. 60180156, 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 H749601827221, REF/Catalog No. 60182722, 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, HOPKINS LEFT HEART, UPN H749601836621, REF/Catalog No. 60183662, 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 H749601900431, REF/Catalog No. 60190043, 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 H749601904231, REF/Catalog No. 60190423, 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 H749601907851, REF/Catalog No. 60190785, 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 H749602000571, REF/Catalog No. 60200057, 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 H749602001451, REF/Catalog No. 60200145, 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 H749602207461, REF/Catalog No. 60220746, 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 H749602301481, REF/Catalog No. 60230148, 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 H749602322341, REF/Catalog No. 60232234, 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 H749606204751, REF/Catalog No. 60620475, 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 H965600125911, REF/Catalog No. 60012591, 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 H9656002072121, REF/Catalog No. 600207212, 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, ANGIO DOUBLE SPIKE KIT, UPN H9656003028111, REF/Catalog No. 600302811, 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 H965600338021, REF/Catalog No. 60033802, 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 H965600416321, REF/Catalog No. 60041632, 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, 3V MANIFOLD KIT, UPN H965601011621, REF/Catalog No. 60101162, 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 H965601017731, REF/Catalog No. 60101773, 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 H965601206511, REF/Catalog No. 60120651, 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, 3V WMMII KIT, UPN H965601852521, REF/Catalog No. 60185252, 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, PTCA KIT, UPN H9656019110161, REF/Catalog No. 601911016, 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 H965601931651, REF/Catalog No. 60193165, 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 H965601955411, REF/Catalog No. 60195541, 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 H965607011741, REF/Catalog No. 60701174, 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, POTENTIAL REVISION TO 600604412, UPN H965PK0604436S1, REF/Catalog No 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 H965PK193168S1, REF/Catalog No 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 H7496002072111, REF/Catalog No. 600207211, 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 Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor The taper adaptor is missing from the packaging, which may result in a delay in surgery greater than 30 minutes. Class IIFDA’s classMar 4, 2015in FDA’s Enforcement Report4 statesnamed in where it went PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereAlabama, Florida, New York and Texas
- Medical device recall COMPASS SW Version 3.1 Error in the software. Class IIFDA’s classMar 4, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereArizona and Oklahoma
- Medical device recall Manual Toothbrush The toothbrush head can potentially disengage from the handle. Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic… Using Merge Exam in single Study Mode may result in Missing Study Record (Cannot Display Exam, Send Exam, etc). Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall The Brainlab Offset Cup Impactor Universal The recommended sterilization and drying parameters are not effective to achieve the minimum required sterilization level. Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Idaho, Illinois, Maryland, Michigan, Minnesota, Ohio, Oklahoma, Oregon, Tennessee, Washington, Wisconsin and West Virginia named
- Medical device recall This correction applies to all GE Healthcare MRI systems with superconducting magnets: Discovery MR450,… At certain sites, the MRU may not be connected to the magnet. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedFeb 25, 2015ClassClass IStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named
- Medical device recall Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body. The MRI system safety feature, which lowers the magnetic field in emergency situations, may not work correctly. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 25, 2015in FDA’s Enforcement ReportMarylandthe one state its words name PublishedFeb 25, 2015ClassClass IStatusTerminatedWhereMaryland
- Medical device recall Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that… Malfunctioning mixing valve and loss of cooling and/or heating capability. Class IIFDA’s classFeb 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedFeb 25, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Connecticut, Florida, Iowa, Illinois, Kansas, Kentucky, Maryland, Michigan, Missouri, Mississippi, New York, Ohio, Pennsylvania, Texas, Utah, Washington and Wisconsin named
- Medical device recall HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200 Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to manually open the grips. Class IIFDA’s classFeb 25, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedFeb 25, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall HARMONIC ACE Curved Shears Instructions for Use, 8MM, IS2000/IS3000 Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to manually open the grips. Class IIFDA’s classFeb 25, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedFeb 25, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures… The possibility exists that the monitor may fail and requires a power circle (shutdown and then power on) to resume operation. Class IIFDA’s classFeb 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 25, 2015ClassClass IIStatusTerminatedWhereNationwide, and Michigan named
- Medical device recall Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic… Internal testing and investigation of the packaging revealed cracks and holes in primary packaging Class IIFDA’s classFeb 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedFeb 25, 2015ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, New Jersey and New York named
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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