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 Product Name: HER2 CISH pharmDx Kit Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed. Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC 60601-1, Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CSI, Diamondback 360 Coronary Orbital Atherectomy System Cardio vascular Systems Inc. Class IIIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedMar 5, 2014ClassClass IIIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Massachusetts, Minnesota, Mississippi, North Carolina, New Jersey, New York, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall Invivo Corporation Expression IP5 Information Portal Product Usage: The Expression Information Portal (Model… Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling their Expression Information Portal (Model IP5). Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee disarticulation amputees OSSUR is recalling the Symbionic Leg because it is not recognizing the low battery warning signal from the Symbionic Leg before it powers down. Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Optiflux F160NRe High Flux Dialyzers Dialysate Port Leak During Priming of the Dialyzers Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Optiflux F160NR High Flux Dialyzers Dialysate Port Leak During Priming of the Dialyzers Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Optiflux F180NRe High Flux Dialyzers Dialysate Port Leak During Priming of the Dialyzers Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Optiflux F180NR High Flux Dialyzers Dialysate Port Leak During Priming of the Dialyzers Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Optiflux F200NRe High Flux Dialyzers Dialysate Port Leak During Priming of the Dialyzers Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Optiflux F200NR High Flux Dialyzers Dialysate Port Leak During Priming of the Dialyzers Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Optiflux F200A High Flux Dialyzers Dialysate Port Leak During Priming of the Dialyzers Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Optiflux B200 Flux Dialyzers Dialysate Port Leak During Priming of the Dialyzers Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Optiflux F18Nre Flux Dialyzers Dialysate Port Leak During Priming of the Dialyzers Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips HeartStart XL+ Defibrillator/Monitor HeartStart XL+ battery charge time to 100% capacity at 35¿C (95¿F) is slightly longer than the specified 3 hour duration as stated in the labeling Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall M3536A HeartStart MRx with Wireless Link Upgrade Wireless Link may be unable to transmit data when configured for a specific data flow. Class IIFDA’s classMar 5, 2014in FDA’s Enforcement Report22 statesnamed in where it went PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereArizona, California, Florida, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas and Virginia
- Medical device recall Philips HeartStart XL, Defibrillator/Monitor Philips HeartStart XL may experience a power board failure causing failure to defibrillate Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips HeartStart MRx Monitor/Defibrillator used HeartStart MRx Defibrillator Monitor therapy connection could experience accelerated wear causing risk for patients and/or caregivers Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall cobas¿ PCR Urine Kit 100 PKT IVD cobas¿ PCR Female Swab Kit 100 PKT IVD cobas¿ PCR media 100T IVD cobas¿ PCR… Numerous complaints have been filed that leaking cobas ¿ PCR media 4.3 mL IVD have been received from different lots of the cobas ¿ PCR Urine kits, cobas ¿ PCR… Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C The product may contain high levels of microbial contamination Class IIFDA’s classMar 5, 2014in FDA’s Enforcement Report7 statesnamed in where it went PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereFlorida, Illinois, Massachusetts, Maine, Michigan, Pennsylvania and Puerto Rico
- Medical device recall PREMIER CARE RECLINER 5570 with Urethane armrests, Multiple side-table options, 3 position lock-bar, Fully… A supplier manufacturing assembly defect with the right hand recline mechanism. Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall CONVALESCENT RECLINER 5251/5261, 525S/526S with Side Storage Pocket, Upholstered side-panels, Recessed… A supplier manufacturing assembly defect with the right hand recline mechanism. Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall DROP-ARM CONVALESCENT RECLINER 5271/5281 with One-touch release for drop-arms, Built-in headrest, Padded… A supplier manufacturing assembly defect with the right hand recline mechanism. Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall XL CONVALESCENT RECLINER 5291/529S with Padded armrests with guard, Dual fold down side-tables, Removable… A supplier manufacturing assembly defect with the right hand recline mechanism. Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Philips HeartStart MRx Monitor/Defibrillator ECG trunk cable and connector block of the MRx could be susceptible to accelerated wear, which could result in an interrupted ECG signal Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J The HeartStart MRx is for use… Philips HeartStart MRx Monitor/Defibrillator, when operating on battery power only, may experience an unexpected shutdown if exposed to elevated levels of… Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic Everest 20cc Inflation Device Incorrect master label. Class IIIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMar 5, 2014ClassClass IIIStatusTerminatedWhereNationwide, and Iowa, Maine, New Hampshire, Oregon, Pennsylvania and Texas named
- Medical device recall Merit Medical’s Custom Procedural Trays or Kits containing 1% Lidocaine HCl Injection, USP, 10 mg/mL Custom Procedural Trays/Kits contain 1% Lidocaine HCl injection which were recalled because one confirmed customer report where visible particulate were found… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedFeb 26, 2014ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690 GE Healthcare has recently become aware of a potential safety issue due to scatter overcorrection associated with the List Mode Replay feature of your… Class IIFDA’s classFeb 26, 2014in FDA’s Enforcement Report30 statesnamed in where it went PublishedFeb 26, 2014ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port2 Docking Station. GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor and Dash Port 2 Docking Station: DASH: 1. Class IIFDA’s classFeb 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Invivo Corporation Expression Information Portal (Model IP5) is intended to be used as a secondary display… Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling the Expression Information Portal (Model IP5). Class IIFDA’s classFeb 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Access 2 Immunoassay System Analyzer The Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access may have been manufactured with non-conforming bushings. Class IIFDA’s classFeb 26, 2014in FDA’s Enforcement ReportSouth Dakotathe one state its words name PublishedFeb 26, 2014ClassClass IIStatusTerminatedWhereSouth Dakota
- Medical device recall UniCel DxI 600 Access Immunoassay System Analyzer The Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access may have been manufactured with non-conforming bushings. Class IIFDA’s classFeb 26, 2014in FDA’s Enforcement ReportSouth Dakotathe one state its words name PublishedFeb 26, 2014ClassClass IIStatusTerminatedWhereSouth Dakota
- Medical device recall Synthes 3.2 mm Guide Wire 400mm Synthes 3.2 mm Guide Wire 400mm included an incorrect raw material listed on the label. Class IIFDA’s classFeb 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SAFSITE¿ Injection Sites and IV Sets Complaints were received reporting leakage on certain lots of SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites.The SAFSITE¿… Class IIFDA’s classFeb 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pediatric… Siemens became aware of an issue where an infant or child could open the tamper resistant battery compartment of the Siemens Prisma 2K hearing aid under… Class IIFDA’s classFeb 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment shunt system is intended to shut… The accuracy is out of specification for the Aesculap proSA Adjustment Disc Size L. Class IIFDA’s classFeb 26, 2014in FDA’s Enforcement Report9 statesnamed in where it went PublishedFeb 26, 2014ClassClass IIStatusTerminatedWhereArizona, Delaware, Florida, Kansas, Massachusetts, Maryland, Michigan, Minnesota and Wisconsin
- Medical device recall Orbit soft Infusion sets, 9 mm soft cannula, P10 Perrigo was notified by our supplier, Ypsomed AG, that they are recalling these batches due to being manufactured with a non-conforming female luer-lock… Class IIFDA’s classFeb 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Georgia and Texas named
- Medical device recall MORPH ACCESSPRO Steerable Introducer Tyvek packaging may be worn, causing loss of package integrity. Class IIFDA’s classFeb 26, 2014in FDA’s Enforcement Report6 statesnamed in where it went PublishedFeb 26, 2014ClassClass IIStatusTerminatedWhereFlorida, Kansas, Massachusetts, Michigan, Ohio and Wyoming
- Medical device recall Synthes Matrix Mandible Short Threaded Drill Guide intended for oral, maxillofacial surgery One lot of Matrix Mandible Short Threaded Drill Guides (part No. Class IIFDA’s classFeb 26, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedFeb 26, 2014ClassClass IIStatusTerminatedWhereCalifornia, Michigan and Texas
- Medical device recall Superstand stand-up wheelchair HPS-2 A standup wheelchair is a device with wheels that is intended for… Power Superstand Standing Wheel chair, flex shaft (the flexible wand which supports the joystick control module) may fracture if it is bent repeatedly and /or… Class IIFDA’s classFeb 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedFeb 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Delaware, Iowa, Illinois, Indiana, Kansas, Kentucky, Michigan, Missouri, New Jersey, Ohio, Oklahoma, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall Integra Cusa Excel The blue COAG button on the CUSA Excel CEM nosecone could stick in the ‘activated’ position. Class IIFDA’s classFeb 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic Select 3D Arterial Cannulae Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the… Class IIFDA’s classFeb 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Medtronic Select 3D Arterial Cannulae Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the… Class IIFDA’s classFeb 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Medtronic Select 3D Arterial Cannulae Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the… Class IIFDA’s classFeb 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Medtronic Select CAP Arterial Cannulae Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the… Class IIFDA’s classFeb 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Medtronic Select CAP Arterial Cannulae Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the… Class IIFDA’s classFeb 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP Arterial Cannulae Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the… Class IIFDA’s classFeb 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico 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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