Medical devices, 2014
Shortlist up to four to read them side by side.
3,059 medical device recalls FDA’s Enforcement Report published in 2014, 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.
3,059of 3,059 medical device recallsshown with your filters
The list
- Medical device recall Stryker 1.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and… There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker 2.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and… There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker 4.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and… There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker 6.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and… There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker 3.0mm Round Fluted Bur Soft Touch Sterile Product Usage: The devices are intended to be used to cut… There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker 5.5mm Round Fluted Bur Soft Touch Sterile Product Usage: The devices are intended to be used to cut… There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker 3.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut… There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker 4.5mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut… There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker 5.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut… There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker 5.5mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut… There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker 6.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut… There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker 2.0mm Tapered Round Elite Bur Sterile Product Usage: The devices are intended to be used to cut bone… There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker 3.5mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut… There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker 5.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut… There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker 6.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut… There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker 2.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut… There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker 5.0mm Egg Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related… There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker 6.0mm Egg Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related… There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker 5.0mm Barrel Bur Sterile There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker 5.0mm Acorn Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone… There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker 6.0mm Acorn Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone… There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Lindemann Drill Short, 1.6mm Sterile Product Usage: The devices are intended to be used to cut bone and bone… There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker 1.3mm Wire Pass Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone… There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker 1.5mm Wire Pass Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone… There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker 2.5mm x 3.6mm Neuro Drill Soft Touch Sterile Product Usage: The devices are intended to be used to… There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker 3.0mm x 3.8mm Neuro Drill Soft Touch Sterile Product Usage: The devices are intended to be used to… There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker 4.0mm x 5.1mm Neuro Drill Soft Touch Sterile Product Usage: The devices are intended to be used to… There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker 3.0mm x 3.8mm Neuro Drill Sterile Product Usage: The devices are intended to be used to cut bone and… There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker 3.0mm x 3.8mm Precision Neuro Drill Sterile Product Usage: The devices are intended to be used to cut… There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker 5.0mm Barrel Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone… There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker 3.0mm x 3.8mm Neuro Drill Less Aggressive Sterile Product Usage: The devices are intended to be used… There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Synthes Matrix Mandible Short Cut Plate Cutter Synthes Matrix Mandible Short Cut Plate Cutter is intended for… It was discovered internally that the face of the Synthes Matrix Mandible Short Cut Plate Cutter has the potential for discoloration/corroded material in the… Class IIFDA’s classJun 18, 2014in FDA’s Enforcement Report7 statesnamed in where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, New York, South Dakota and Texas
- Medical device recall Cooper Surgical TAMPA CATHETER 5 French 33 cm Sterility of the device may be compromised due to unsealed pouch Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Connecticut, Florida, Massachusetts, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Virginia and Vermont named
- Medical device recall Philips IntellVue Info Center iX 866023 If a customer creates customized trend scales in the trend review tile and the iX or primary server reboots for any reason, the iX(s) will enter a reboot loop. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cordis EMPIRA RX PTCA Dilatation Catheter Dilatation catheters could exhibit radial versus axial tears should they burst during inflation. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement Report9 statesnamed in where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereArizona, Florida, Illinois, Louisiana, Massachusetts, New Jersey, Oregon, South Carolina and Texas
- Medical device recall Taut Operative Cholangiogram Catheter, 4.5FR Several complaints were received for the metal support tube missing from the cholangiogram catheter. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement Report18 statesnamed in where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Illinois, Louisiana, Maine, Michigan, Missouri, New York, Ohio, Oregon, Tennessee, Texas, Vermont and Wisconsin
- Medical device recall Beekley Spots Light Image O-Spots for Mammography Light Image O-Spots Dispenser mislabeled as Soft n’ Stretchy Light Image S-Spots Class IIIFDA’s classJun 18, 2014in FDA’s Enforcement Report6 statesnamed in where it went PublishedJun 18, 2014ClassClass IIIStatusTerminatedWhereCalifornia, Florida, Massachusetts, North Carolina, New York and Pennsylvania
- Medical device recall Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed… There is a potential safety risk associated with potentially damaged locking pins within the bracket of non-wireless versions of Continuum systems shipped… Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BG3515-5 US 5mL BioGlue Surgical Adhesive Serum albumin component monomer failed to meet internally established end of shelf-life specification. Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Integra Licox Test Kit Integra LifeSciences has identified through a small number of complaints that some lot numbers of Licox Test Kits (Catalog Number BC10R) may provide erroneous… Class IIFDA’s classJun 11, 2014in FDA’s Enforcement Report7 statesnamed in where it went PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereFlorida, Illinois, Massachusetts, Maryland, North Carolina, Pennsylvania and South Dakota
- Medical device recall Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt System… AIC (USA) received information regarding 3 complaints in which the deflector did not move freely on the ventricular catheter. Class IIFDA’s classJun 11, 2014in FDA’s Enforcement Report10 statesnamed in where it went PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereConnecticut, Kansas, Kentucky, New York, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas and Washington
- Medical device recall enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM)… Software Anomaly: Ortho Clinical Diagnostics (OCD) has become aware that if a sample requires follow-up action, such as dilution or retesting due to a… Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall IntelliSpace Portal (ISP), (ISP DX/HX/EX During SPECT reconstructions using Attenuation Correction and Scatter Correction, no Scatter Correction is being applied in the AutoSPECT Pro application on… Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 115 V Blanketrol II The incorrect voltage component was placed into the device during manufacturing. Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportMichiganthe one state its words name PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereMichigan
- Medical device recall Wound Drain - Label reads in part “Elutia ***Hubless Coated Silicone Surgical Wound Drain***” Two different… The recalling firm reported there was inadvertent omission of quarterly (Q4 - 2013 and Q1 - 2014) dose audits/verifications on the affected products. Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral… Two lots of the Synthes XRL Medium Trial-Central Body device were incorrectly etched with the incorrect dimensions for height. Class IIFDA’s classJun 11, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereFlorida, Minnesota and New Jersey
- Medical device recall Composix” LP with Echo PS” 10x13 HUXH0294 HUXL0314 Indicated for use in the reconstruction of soft tissue… Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Composix” LP with Echo PS” 6x10 Reorder Number: 0144610 Indicated for use in the reconstruction of soft… Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide
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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