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 Transpac IV Trifurcated Monitoring Kit w/84” Safeset Reservoir, 03 ml Squeeze Flush and 2 Clave Sampling Ports ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak. Class IIFDA’s classAug 13, 2014in FDA’s Enforcement ReportOregonthe one state its words name PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereOregon
- Medical device recall Trifurcated Transpac IT Monitoring Kit w/03 ml Flush Devices, Needleless Valve and Macrodrip ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak. Class IIFDA’s classAug 13, 2014in FDA’s Enforcement ReportOregonthe one state its words name PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereOregon
- Medical device recall Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Patient Mount ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak. Class IIFDA’s classAug 13, 2014in FDA’s Enforcement ReportOregonthe one state its words name PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereOregon
- Medical device recall Trifurcated Transpac IV Monitoring Kit w/Safeset Reservoir, 03 ml Squeeze Flush and 6 Needleless Valves ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak. Class IIFDA’s classAug 13, 2014in FDA’s Enforcement ReportOregonthe one state its words name PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereOregon
- Medical device recall Single Transpac IT Monitoring Kit w/03 ml Flush Device, Needleless Valve, Macrodrip ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak. Class IIFDA’s classAug 13, 2014in FDA’s Enforcement ReportOregonthe one state its words name PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereOregon
- Medical device recall Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and 2 CSP ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak. Class IIFDA’s classAug 13, 2014in FDA’s Enforcement ReportOregonthe one state its words name PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereOregon
- Medical device recall Transpac IT w/3 ML/HR Macrodrip, Arterial Pressure Tubing and CSP ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak. Class IIFDA’s classAug 13, 2014in FDA’s Enforcement ReportOregonthe one state its words name PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereOregon
- Medical device recall Single Line Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, CSP and Blue Stripe Tubing ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak. Class IIFDA’s classAug 13, 2014in FDA’s Enforcement ReportOregonthe one state its words name PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereOregon
- Medical device recall Transpac IT w/10 cc Safeset Reservoir, 03 ml Flush Device, 2 CSP and Red Stripe Tubing ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak. Class IIFDA’s classAug 13, 2014in FDA’s Enforcement ReportOregonthe one state its words name PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereOregon
- Medical device recall PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6 Potential for demographic information and test result to be mismatch. Class IIFDA’s classAug 13, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereFlorida, Georgia, Massachusetts and Nevada
- Medical device recall IPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the management of wound healing. Potential for microbial contamination of the product. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 6, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedAug 6, 2014ClassClass IStatusTerminatedWhereAlabama, Arkansas, Georgia, Illinois, Kentucky, Louisiana, Missouri, Mississippi, New Jersey, South Carolina, Tennessee, Texas and Virginia
- Medical device recall CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 per case “THIS SIDE UP” is on the wrong side of the product. Class IIFDA’s classAug 6, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 6, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Medtronic Nexdrive Micropositioning Drive Potential for misalignment of the Z-stage scale. Class IIFDA’s classAug 6, 2014in FDA’s Enforcement Report15 statesnamed in where it went PublishedAug 6, 2014ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Illinois, Kansas, Kentucky, Louisiana, Minnesota, Montana, North Carolina, Nebraska, Oregon, Texas, Utah and Virginia
- Medical device recall Emerald Fiberoptic Blade, Macintosh 4, Teleflex Medical Packaging Error: Customers have reported receiving incorrect product. Class IIFDA’s classAug 6, 2014in FDA’s Enforcement Report9 statesnamed in where it went PublishedAug 6, 2014ClassClass IIStatusTerminatedWhereFlorida, Georgia, Kentucky, Maryland, Mississippi, Montana, Pennsylvania, South Carolina and Texas
- Medical device recall Horizon Medical Imaging It is a medical image and information management application that is intended to… The firm has identified a software issue which may cause a discrepancy between the index of images expected by the application, and the actual content of the… Class IIFDA’s classAug 6, 2014in FDA’s Enforcement Report48 statesnamed in where it went PublishedAug 6, 2014ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall InTouch Critical Care Bed, Stryker Medical Stryker has received complaints from the field alleging instances where the In Touch beds are hoisted or lifted from the floor and the casters have fallen off. Class IIFDA’s classAug 6, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedAug 6, 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, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall PHAROS Excimer Laser RA Medical Systems is recalling the PHAROS EX-308 Excimer Laser because there is a possibility that the laser may calibrate with the iris closed. Class IIFDA’s classAug 6, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DeRoyal KNEE ARTHROSCOPY PACK The firm distributed surgical kits which contained Irrigation Sets which were subsequently recalled by Hospira. Class IIFDA’s classAug 6, 2014in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 6, 2014ClassClass IIStatusTerminatedWhereGeorgia, Illinois, Indiana, Michigan, Missouri and Ohio
- Medical device recall DeRoyal Cardiac Hypothermia Tray The firm distributed surgical kits which contained Irrigation Sets which were subsequently recalled by Hospira. Class IIFDA’s classAug 6, 2014in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 6, 2014ClassClass IIStatusTerminatedWhereGeorgia, Illinois, Indiana, Michigan, Missouri and Ohio
- Medical device recall FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used in the end-to-end… Baxter Healthcare is recalling the FlowCOUPLER Device because there is a possibility that some units may not maintain electrical continuity during handling… Class IIFDA’s classAug 6, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Small Bone Innovations 3.0/4.0mm AutoFIX” Cannulated Compression Screw System Sets, Implants, and Instruments… Small Bone Innovations (SBi) is recalling all lots of 3.0/4.0mm AutoFIX” Cannulated Compression Screw System Sets, Implants, and Instruments to update the IFU. Class IIFDA’s classAug 6, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedAug 6, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Indiana, Missouri, North Carolina, New Hampshire, New York, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas and Washington named
- Medical device recall Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50 0.125 mL unit dose tips, 50… Septodont is recalling Self-Etch bond because the material was incorrectly packaged. Class IIFDA’s classAug 6, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 6, 2014ClassClass IIStatusTerminatedWhereNew York and Pennsylvania
- Medical device recall Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing Septodont is recalling Self-Etch bond because the material was incorrectly packaged. Class IIFDA’s classAug 6, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 6, 2014ClassClass IIStatusTerminatedWhereNew York and Pennsylvania
- Medical device recall RUSCH, TruLite, One-Piece Disposable Laryngoscope Handle Blade Combination, Non-Sterile There is a possibility the handle of the laryngoscope may heat up and melt the end cap. Class IIFDA’s classAug 6, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer Periarticular Locking Plate System Distal Radial Volar Plate Lateral Column A complaint was received in which it was reported that an 8-hole plate from lot 62276042 had an enlarged hole that is unable to lock the screw, which resulted… Class IIFDA’s classAug 6, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 6, 2014ClassClass IIStatusTerminatedWhereCalifornia and Ohio
- Medical device recall MC-500 Multicolor Laser Photocoagulator Laser aperture label was not affixed to device prior to shipment in the US. Class IIFDA’s classAug 6, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedAug 6, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Kansas, Michigan, Minnesota, Missouri, Nebraska, New Hampshire, New York, Oregon, Pennsylvania, Texas, Utah and Wisconsin named
- Medical device recall Dimension¿ Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids. There is a misassembly issue with the photometer installed on Dimension¿ Integrated Chemistry Systems instruments. Class IIIFDA’s classAug 6, 2014in FDA’s Enforcement Report9 statesnamed in where it went PublishedAug 6, 2014ClassClass IIIStatusTerminatedWhereArkansas, Florida, Iowa, Illinois, Kansas, Louisiana, Montana, Ohio and Wisconsin
- Medical device recall Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital… The following defects have been identified for data loaded with Patient Data Manager version 2.0 (including subversions 2.0.0, 2.0.1 and 2.0.2): 1) When… Class IIFDA’s classAug 6, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedAug 6, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Florida, Georgia, Iowa, Illinois, Kansas, Maryland, Missouri, Mississippi, North Carolina, New York, Ohio, Pennsylvania, South Dakota, Texas, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall ADVOCATE Redi-Code+ BMB-BA006A Blood Glucose test strips Product Usage: The ADVOCATE¿ Redi-Code+ BMB-BA006A… “Advocate Redi-Code + BMB-BA006A Blood Glucose test strips” are inappropriately labeled and marketed as “Advocate Redi-Code + Blood Glucose test strips”. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 30, 2014ClassClass IStatusTerminatedWhereNationwide
- Medical device recall DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES Failure of the CO2 detector in Single-width Airway and Extension modules, which may cause a slow continuous decrease of measured Et-/FiCO2 values. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 30, 2014ClassClass IStatusTerminatedWhereNationwide
- Medical device recall RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate RAPIDPoint 500 Measurement Cartridges may have an error code one or more electrolyte parameters (e.g., Na+, Ca++, K+, Cl-) Class IIFDA’s classJul 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 30, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip Internal review found that six lots of Disposable StrykeFlow Tips were shipped with a potentially deformed blister pouch which could impact sterility of the… Class IIFDA’s classJul 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 30, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AGFA Digital Radiography X-Ray system DX-D 100 Agfa’s DX-D 100 is indicated for use in providing diagnostic… When liquid comes in contact with the DX-D 100 touch screen, the device may incorrectly recognize this as user input altering device settings. Class IIFDA’s classJul 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedJul 30, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, South Carolina, Tennessee, Texas, Virginia, Wisconsin, West Virginia and Wyoming named
- Medical device recall RECLAIM Taper Protector Sleeve The product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming. Class IIFDA’s classJul 30, 2014in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 30, 2014ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes The product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming. Class IIFDA’s classJul 30, 2014in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 30, 2014ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall RECLAIM DISTAL TAPERED Distal Stem, various sizes The product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming. Class IIFDA’s classJul 30, 2014in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 30, 2014ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall GE Healthcare, CARESCAPE Monitor B850, B650 or B450 Partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. Class IIFDA’s classJul 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 30, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit The femoral stem is lacking specified plasma coating. Class IIFDA’s classJul 30, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 30, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System) The Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System) were found to be labeled incorrectly. Class IIFDA’s classJul 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 30, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hemochron Jr Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized blood samples. Class IIFDA’s classJul 30, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 30, 2014ClassClass IIStatusTerminatedWhereGeorgia, New York and Virginia
- Medical device recall Perouse Flamingo Perouse Medical in France initiated a voluntary recall of certain batches of Perouse FLAMINGO Inflations Devices due to a potential water-tightness default. Class IIFDA’s classJul 30, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 30, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (NIMH) Battery Typographical error in the Japanese legal label of the AutoPulse Resuscitation System Model 100. Class IIIFDA’s classJul 30, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 30, 2014ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall MK5 NX Controller--Wheelchair controller M41 Powered Wheelchairs received through Invacare Service Parts (ISP) have controllers that were programmed in a way this is not aligned to standard factory… Class IIFDA’s classJul 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedJul 30, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Solanas 2.1mm FIXED DEPTH DRILL, 10mm Alphatec Spine is recalling the 2.1mm Fixed Depth Drill 10mm because they received a report that the instrument malfunctioned and golden stop slid from its… Class IIFDA’s classJul 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 30, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Connecticut, Illinois, North Carolina, New York and West Virginia named
- Medical device recall Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather, with 7 foot… The case label correctly states partial rebreather but the insert label incorrectly states non-rebreather. Class IIFDA’s classJul 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 30, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sarns D4 Aortic Arch Cannulae 6.0mm, 7mm & 8mm angled and straight tip with or without side holes and/or luer… During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product… Class IIFDA’s classJul 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedJul 30, 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, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Sarns Flexible Aortic Arch Cannula 8.0mm with luer, 3/8” connector Product Usage: The Aortic Cannula is… During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product… Class IIFDA’s classJul 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedJul 30, 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, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Sarns Malleable Dual-stage Venous Return Cannulae 28/38, 32/40 & 34/46 Fr with 1/2” connector with or without… During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product… Class IIFDA’s classJul 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedJul 30, 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, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming 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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