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 6, 2026.
3,059of 3,059 medical device recallsshown with your filters
The list
- Medical device recall ADVIA Centaur XP Immunoassay System The firm is conducting a field correction for the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems, regarding manually loaded sample racks that are… Class IIFDA’s classSep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional… During a Field Test (a customer external evaluation period), the customer detected a problem in the CIRS 4.0 Beta 2 software. Class IIFDA’s classSep 24, 2014in FDA’s Enforcement ReportOhiothe one state its words name PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereOhio
- Medical device recall Siemens CentraLink Data Management System, software version 14 Siemens Healthcare Diagnostics has identified a task scheduler issue with the CentraLink" Data Management System, software version 14. Class IIFDA’s classSep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall The Brilliance CT Big Bore is a whole-body Computed Tomography X-ray system intended to produce… Philips Healthcare received a complaint stating the system opens e-stop while sitting idle causing all movements and scan to stop. Class IIFDA’s classSep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes. Class IIFDA’s classSep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson/Monoject Syringe Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes. Class IIFDA’s classSep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes. Class IIFDA’s classSep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens Luminos dRF, Ysio or Uroskop Omnia systems It was discovered that during a RAD examination using Siemens Luminos dRF, Ysio or Uroskop Omnia systems with software version VB10C to VB10F and automatic… Class IIFDA’s classSep 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 17, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography. Unsealed pouches. Class IIFDA’s classSep 17, 2014in FDA’s Enforcement Report18 statesnamed in where it went PublishedSep 17, 2014ClassClass IIStatusTerminatedWhereCalifornia, Colorado, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Maryland, Michigan, Mississippi, North Carolina, New Jersey, New York, Oregon, Pennsylvania, Texas and Washington
- Medical device recall BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments… Identifiers on the label are correct but the label has the incorrect color coding. Class IIFDA’s classSep 17, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 17, 2014ClassClass IIStatusTerminatedWhereNew Hampshire and Texas
- Medical device recall DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves Catheter Connections is recalling DualCap IV Pole Strips disinfectant caps for luer access valves due to potential improper packaging cap seal which may render… Class IIFDA’s classSep 17, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 17, 2014ClassClass IIStatusTerminatedWhereConnecticut, Georgia, Maryland and Pennsylvania
- Medical device recall Prime Care ¿ Transcend Mattress, Prime Care ¿ Transcend Perimeter Mattress, Prime Care ¿ Transcend Advanced… The firm found that the top cover of the mattresses were delaminating. Class IIFDA’s classSep 17, 2014in FDA’s Enforcement Report19 statesnamed in where it went PublishedSep 17, 2014ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Illinois, Kansas, Maryland, Minnesota, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Pennsylvania, Texas, Utah, Virginia and Washington
- Medical device recall RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing application for clinical use… Recalled by FDA on Sep 17, 2014 Class IIFDA’s classSep 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedSep 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Missouri, Mississippi, Texas and Utah named
- Medical device recall Merci Retriever Intended to restore blood flow in the neurovasculature by removing thrombus in patients… Merci Retrievers were shipped to US customers past their expiration date, even though they were labeled with the correct expiration date. Class IIFDA’s classSep 17, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedSep 17, 2014ClassClass IIStatusTerminatedWhereCalifornia, New Mexico, Ohio, Pennsylvania and Texas
- Medical device recall CLAW PLATE 20mm INTERAXIS CHARLOTTE F&A SYSTEM Plates manufactured from an incorrect raw material. Class IIFDA’s classSep 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 17, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CLAW 3.5mm PLATE CHARLOTTE F&A SYSTEM, SIZE 30mm, 2 HOLE, USE WITH 3.5mm CLAW SCREW Plates manufactured from an incorrect raw material. Class IIFDA’s classSep 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 17, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 15mm Plates manufactured from an incorrect raw material. Class IIFDA’s classSep 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 17, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 20mm Plates manufactured from an incorrect raw material. Class IIFDA’s classSep 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 17, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 25mm Plates manufactured from an incorrect raw material. Class IIFDA’s classSep 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 17, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 30mm Plates manufactured from an incorrect raw material. Class IIFDA’s classSep 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 17, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 20mm Plates manufactured from an incorrect raw material. Class IIFDA’s classSep 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 17, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 25mm x 25mm Plates manufactured from an incorrect raw material. Class IIFDA’s classSep 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 17, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 25mm Plates manufactured from an incorrect raw material. Class IIFDA’s classSep 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 17, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AB SCIEX API 3200MD” LC/MS/MS System with software: MultiQuantMD 3.0In vitro diagnostic to identify inorganic… Software- AB SCIEX API 3200MD LC/MS/MS SYSTEM with MultiQuantMD 3.0 software may provide incorrect data for patient diagnosis Class IIFDA’s classSep 17, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedSep 17, 2014ClassClass IIStatusTerminatedWhereFlorida, North Carolina, Oklahoma, Pennsylvania and Texas
- Medical device recall PROXIMATE Skin Stapler The device may have a non-conforming component that may cause the device to fire an unformed staple. Class IIFDA’s classSep 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedSep 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, 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 named
- Medical device recall Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.15, fails to perform as intended Class IIFDA’s classSep 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 17, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ***Baxter***Buretrol Solution Set***105” Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solution set product codes due to complaints for separation between… Class IIFDA’s classSep 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 17, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ***Baxter***BURETROL Solution Set***105” Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solution set product codes due to complaints for separation between… Class IIFDA’s classSep 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 17, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ***Baxter***Non-DEHP***BURETROL Solution Set 105” Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solution set product codes due to complaints for separation between… Class IIFDA’s classSep 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 17, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE The affected fixed rod holders did not allow the instrument to lock down on the spinal rod. Class IIFDA’s classSep 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedSep 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois and Texas named
- Medical device recall CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE GE Healthcare has recently become aware of a potential safety issue due to a failure of an O2 sensor component associated with the CARESCAPE respiratory… Class IIFDA’s classSep 17, 2014in FDA’s Enforcement Report18 statesnamed in where it went PublishedSep 17, 2014ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Georgia, Indiana, Kentucky, Louisiana, Maryland, Michigan, North Carolina, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall The BD MAX MRSA Assay, catalogue #442953 The performance of the assay no longer conforms to this statement in the Analytical Specificity section of the Package Insert: One hundred-eleven (111) out of… Class IIFDA’s classSep 17, 2014in FDA’s Enforcement Report26 statesnamed in where it went PublishedSep 17, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, Hawaii, Illinois, Indiana, Maryland, Michigan, Minnesota, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Hancock Apical Left Ventricle Connector Medtronic has decided to discontinue production and distribution of this low-volume product. Class IIFDA’s classSep 17, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 17, 2014ClassClass IIStatusTerminatedWhereMaryland and Texas
- Medical device recall Integra Container Lid, ¿¿ Size, Red Integra LifeSciences has identified through an internal investigation that some colored lids for Integra container systems were not yet cleared by the FDA for… Class IIFDA’s classSep 17, 2014in FDA’s Enforcement ReportFloridathe one state its words name PublishedSep 17, 2014ClassClass IIStatusTerminatedWhereFlorida
- Medical device recall Life Force Chamber Product Usage:The product is intended for restful contemplation and spirituality. The Life Force chamber is marketed and promoted as a medical device, intended for use in the diagnosis of disease or other conditions or in the cure,… Class IIFDA’s classSep 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedSep 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Florida, Maryland, Nevada, Oklahoma, Pennsylvania and Texas named
- Medical device recall Stryker Aria Implant Inserter Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to complaints of product fracturing. Class IIFDA’s classSep 17, 2014in FDA’s Enforcement Report24 statesnamed in where it went PublishedSep 17, 2014ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah and Wisconsin
- Medical device recall Specialty Aria Inserter Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to complaints of product fracturing. Class IIFDA’s classSep 17, 2014in FDA’s Enforcement Report24 statesnamed in where it went PublishedSep 17, 2014ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah and Wisconsin
- Medical device recall Customed Angiodrape Pack convenience pack include multiple components: syringe 10cc and 30cc, gauze, denture… Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall Customed O.B Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall Customed Laparoscopy convenience pack include multiple components: gowns, table covers, needle and blade… Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall Customed Major Laparotomy Pack , convenience pack include multiple components: Mayo stand cover, absorbent… Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall Customed Cysto Tur Pack, convenience pack include multiple components: legging with cuff, drape cystoscopy,… Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall Customed Laparotomy Pack , convenience pack include multiple components: drape laparot., gown, absorbent… Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall Customed Femoral Pack , convenience pack include multiple components: Syringe 3cc, 5cc, 10cc, 20cc Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall Customed LABOR & DELIVERY PACK - Includes Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall Universal Pack Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall OPEN HEART TRAY - PACK Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall LAPAROTOMY PACK - CUSTOMED Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands 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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