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 Persona (TM) The Personalized Knee System CR Tibial Articular Surface Provisional Top Nonsterile TASP CR L… Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). Class IIFDA’s classAug 27, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedAug 27, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Persona (TM) The Personalized Knee System UC Tibial Articular Surface Provisional Top Nonsterile TASP UC L… Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). Class IIFDA’s classAug 27, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedAug 27, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional Bottom Nonsterile PSN A/S PROV… Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). Class IIFDA’s classAug 27, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedAug 27, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Persona (TM) The Personalized Knee System CPS Tibial Articular Surface Provisional Top Nonsterile TASP MLC L… Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). Class IIFDA’s classAug 27, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedAug 27, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton… Philips IntelliSpace ECG (IECG) Management Systems that are importing Stress ECG records from a Quinton Stress ECG system have the potential for the patient… Class IIFDA’s classAug 27, 2014in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 27, 2014ClassClass IIStatusTerminatedWhereCalifornia, Georgia, North Carolina, New Hampshire, New York and Oregon
- Medical device recall GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoagulator Laser Aperture label was not applied to certain GYC-1000 Green Laser Photocoagulators devices in the field as per FDA regulation, Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Enhancement Medical expression Manufacturer made a change in the production process that resulted in a change in final gel weight. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 20, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 20, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System CSI has initiated a recall on the Diamondback 360 Peripheral Orbital Atherectomy Device because it may contain a saline sheath that may experience cracking,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 20, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedAug 20, 2014ClassClass IStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Connecticut, Florida, Iowa, Illinois, Maryland, Michigan, North Carolina, New York, Pennsylvania, Tennessee and Texas named
- Medical device recall Esaote PA230E Transducer A portable and cart base ultrasound system for general and cardiovascular imaging Using the PA230E transducer with a user-defined setting with the output power to 100% (Max) in 2D-TEI mode focusing at maximum depth, could cause the… Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, 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 Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigene CDF… Nanosphere has received report of an increased rate of “No Call - INT CTL 2” results for the Internal Control 2 (INT CTL 2) when negative samples are tested… Class IIIFDA’s classAug 20, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 20, 2014ClassClass IIIStatusTerminatedWhereCalifornia and Washington
- Medical device recall 5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Handling System) Abbott Molecular identified that some of the 5 ml Reaction Vessels (RVs) contained in lots 56944001, 57026001, 57059001, and 57673001 (original vendor lot… Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene… Nanosphere has determined that a portion of BC-GN Test Cartridge Lot number 040214021A has an elevated risk for No Call results and False Negative results. Class IIFDA’s classAug 20, 2014in FDA’s Enforcement Report10 statesnamed in where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Nebraska, New Jersey, New York, Texas and Wisconsin
- Medical device recall EndoWrist Stapler System User Manual Addendum and Wall Chart Changes were made to the Stapler EndoWrist Stapler 45 System Instruments and Accessories User Manual Addendum (550986-03) and the EndoWrist Stapler 45 Wall… Class IIFDA’s classAug 20, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereFlorida and South Carolina
- Medical device recall Medtronic Ascenda Intrathecal Catheter models 8780 and 8781, and Ascenda Intrathecal Catheter Pump Segment… Medtronic is removing specific lots of the Ascenda Intrathecal Catheters and Revision Kits, which are used with the implantable SynchroMed drug infusion pump. Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Medtronic MiniMed Implantable Insulin Pump Medtronic MiniMed is recalling the Implantable Insulin Pump because there have been reports of a pump malfunction resulting in the disconnection of the… Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNew Jersey
- Medical device recall Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic Sequenced Cancer Treatment… A safety risk exists with automatically sequenced treatment technique using the SIMTEC Auto Field Option where automatic movements of the gantry and the… Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in providing diagnostic quality images to… Some customers reported that while using the DX-D600 in room or exam preparation, the Overhead Tube Crane (OTC) showed increased velocity and uncontrolled… Class IIFDA’s classAug 20, 2014in FDA’s Enforcement Report9 statesnamed in where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereDistrict of Columbia, Georgia, Indiana, Kansas, Kentucky, Massachusetts, New Jersey, South Carolina and Virginia
- Medical device recall Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic… Unit was mislabeled with a factory label showing 32 KW output power. Class IIIFDA’s classAug 20, 2014in FDA’s Enforcement ReportWest Virginiathe one state its words name PublishedAug 20, 2014ClassClass IIIStatusTerminatedWhereWest Virginia
- Medical device recall Kodak DirectView DR 7500 Diagnostic X-Ray System Product Usage: The DR 7500 system is a permanently installed… An on-site evaluation of the equipment parts that attach the Beta Assembly (x-ray tube and collimator) to the Over Head Tube Crane (OTC) Telescope was… Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Radiomat M+ NIF 14 x 17 Some sheets of the medical screen film are fogged. Class IIIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedAug 20, 2014ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Illinois, Louisiana, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Hampshire and New Jersey named
- Medical device recall Medtronic MiniMed Guardian Monitor Medtronic MiniMed is recalling the Guardian REAL-Time monitors because of a manufacturing issue that has the potential to compromise the water resistance of… Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens Syngo RT Therapist and Syngo RT Oncologist intended use of the SIEMENS branded Syngo RT Therapist and… Siemens became aware of a potential issue with the syngo RT Therapist 4.3.SP1 and syngo RT Oncologist 4.3SP1 software applications running on Siemens brand… Class IIFDA’s classAug 20, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNew York, Utah and Wisconsin
- Medical device recall Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for… Beevers Manufacturing & Supply Inc. Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Integra NewPort MIS System Integra LifeSciences is recalling the Integra NewPort MIS System because there is a possibility that components from the demonstration set may have been mixed… Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportTexasthe one state its words name PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereTexas
- Medical device recall VITROS¿ Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs Customers may receive positively biased results when using VITROS¿ Immunodiagnostic Products CA 19-9 Total Reagent Packs, Lot 1320 and VITROS¿ CA 19-9… Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Codman Certas - In Line Valve Only To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product’s Instructions for Use (IFU). Class IIFDA’s classAug 20, 2014in FDA’s Enforcement Report43 statesnamed in where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Codman Certas - In Line Valve with Catheter and Accessories To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product’s Instructions for Use (IFU). Class IIFDA’s classAug 20, 2014in FDA’s Enforcement Report43 statesnamed in where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Codman Certas - In Line Valve with Unitized Catheter and Accessories To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product’s Instructions for Use (IFU). Class IIFDA’s classAug 20, 2014in FDA’s Enforcement Report43 statesnamed in where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Codman Certas - In line Valve with Unitized BACTISEAL¿ Catheter and Accessories To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product’s Instructions for Use (IFU). Class IIFDA’s classAug 20, 2014in FDA’s Enforcement Report43 statesnamed in where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Codman Certas - In Line Valve only with SIPHONGUARD¿ Device To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product’s Instructions for Use (IFU). Class IIFDA’s classAug 20, 2014in FDA’s Enforcement Report43 statesnamed in where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Catheter and Accessories To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product’s Instructions for Use (IFU). Class IIFDA’s classAug 20, 2014in FDA’s Enforcement Report43 statesnamed in where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Codman Certas - In Line Valve with SIPHONGUARD¿, Unitized Catheter and Accessories To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product’s Instructions for Use (IFU). Class IIFDA’s classAug 20, 2014in FDA’s Enforcement Report43 statesnamed in where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Unitized BACTISEAL¿ Catheter and Accessories To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product’s Instructions for Use (IFU). Class IIFDA’s classAug 20, 2014in FDA’s Enforcement Report43 statesnamed in where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Prismaflex TPE 2000 set, Product Number 1071441 Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Prisma TPE 2000 set Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Prisma M 60 PRE set (new design) Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Prisma M60 POSTDILUTION set Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Prisma M 100 PRE set Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Prisma M100 set Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Prisma M100 PRE pump infusion set Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Prisma HF1000 preset (new design) Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Prismaflex M60 set Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Prismaflex M100 Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Prismaflex M150 Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Prismaflex HF 1000 Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Prismaflex HF 1400 Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment Kit per carton box,… Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541 Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNo state 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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