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 System Manual for the da Vinci Standard Surgical System Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci… Class IIFDA’s classJul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Endowrist Instrument and Accessory Manual for the da Vinci Standard Surgical System Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci… Class IIFDA’s classJul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vision Troubleshooting Guide for the da Vinci Standard Surgical System Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci… Class IIFDA’s classJul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Insert for IRK for the da Vinci Standard Surgical System Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci… Class IIFDA’s classJul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stapler Addendum for the da Vinci Standard Surgical System Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci… Class IIFDA’s classJul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vessel Sealer Addendum for the da Vinci Standard Surgical System Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci… Class IIFDA’s classJul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vessel Sealer QRG for the da Vinci Standard Surgical System Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci… Class IIFDA’s classJul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Single Site US Manuals and Single Site OUS Manuals for the da Vinci Standard Surgical System Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci… Class IIFDA’s classJul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IRK QRG for the da Vinci Standard Surgical System Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci… Class IIFDA’s classJul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cautery QRG for the da Vinci Standard Surgical System Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci… Class IIFDA’s classJul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Connection QRG for the da Vinci Standard Surgical System Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci… Class IIFDA’s classJul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Natural Rubber Latex QRG for the da Vinci Standard Surgical System Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci… Class IIFDA’s classJul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Integra¿ LED Battery Charger, Single Bay LED battery chargers may prematurely fail and will not charge the LED battery as intended Class IIFDA’s classJul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics. Laser cooling fans and internal fan of the associated fluidics cart are not operational. Class IIFDA’s classJul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Georgia, Iowa, Maryland, Minnesota, New Jersey, New Mexico, New York, Ohio, Rhode Island and West Virginia named
- Medical device recall Stryker Orthopaedics Triathlon Tritanium Patella Inserter Tritanium Patella Inserter Instrument fracture during implantation. Class IIFDA’s classJul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Florida, Kentucky, Louisiana and New Jersey named
- Medical device recall CNS-6200 Series Central Nurse Station and accessories Software Version 02-26, when used with the Central Nursing Station (CNS) 6201, (PU-621 RA) may unexpectedly and without warning reboot, resulting in a period… Class IIFDA’s classJul 9, 2014in FDA’s Enforcement ReportOklahomathe one state its words name PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereOklahoma
- Medical device recall Non-Mydriatic Auto Fundus Camera Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image. Class IIFDA’s classJul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Langston Dual Lumen Catheters, 6Fr The inner catheter of some Langston V2 Dual Lumen Catheters have separated from the device hub during contrast pressure injections. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 9, 2014ClassClass IStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall BrightView XCT Flat Panel Display (FPD) failed to remain securely locked in the deployed position. Class IIFDA’s classJul 9, 2014in FDA’s Enforcement Report32 statesnamed in where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereArizona, California, Colorado, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Kentucky, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Texas, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Anspach Pneumatic and Electric Motor Systems Several attachments and handpieces failed to meet the expected sterility assurance level (SAL) when sterilized by the method that is specified in the current… Class IIFDA’s classJul 9, 2014in FDA’s Enforcement Report52 statesnamed in where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Synthes B37 Replacement Screws All lots of B37 Replacement Screws are being recalled due to potential mislabeling where the package may not contain the screws identified on the label. Class IIFDA’s classJul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, District of Columbia, Florida, Illinois, Kansas, Kentucky, Oklahoma, Pennsylvania and Washington named
- Medical device recall Siemens Mobilett XP Digital Mobile X-ray System Product Usage: The Mobilett XP and Mobilett XP Hybrid are… There is a potential fire hazard of certain Lithium-Ion batteries in the computers used in the original manufacturing or as spare parts between October 2010… Class IIFDA’s classJul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Missouri, New Jersey, New Mexico and Pennsylvania named
- Medical device recall Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw Class IIFDA’s classJul 9, 2014in FDA’s Enforcement Report10 statesnamed in where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereCalifornia, Hawaii, Idaho, Massachusetts, Michigan, Mississippi, Pennsylvania, Tennessee, Texas and Utah
- Medical device recall Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips (Reusable) Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw Class IIFDA’s classJul 9, 2014in FDA’s Enforcement Report10 statesnamed in where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereCalifornia, Hawaii, Idaho, Massachusetts, Michigan, Mississippi, Pennsylvania, Tennessee, Texas and Utah
- Medical device recall GE Healthcare, Proteus XR/a GE Healthcare has become aware of a potential safety issue due to a collimator installation error during a service maintenance activity involving the Proteus… Class IIFDA’s classJul 9, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereDistrict of Columbia, Guam and Puerto Rico
- Medical device recall GE Healthcare, Revolution XR/d GE Healthcare has become aware of a potential safety issue due to a collimator installation error during a service maintenance activity involving the Proteus… Class IIFDA’s classJul 9, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereDistrict of Columbia, Guam and Puerto Rico
- Medical device recall MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge Springs contained in the access door hinge assembly on the Walk Away Plus instruments are becoming detached causing premature failure of the hinge assembly and… Class IIFDA’s classJul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ADVIA Centaur¿ Systems TnI-Ultra assay The solid phase reagent in some of the ADVIA Centaur¿ TnI -Ultra ReadyPacks¿, lot 084, is darker in appearance, creating a potential for incorrect control and… Class IIFDA’s classJul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System & Brilliance CT Big Bore… During internal testing, the Brilliance CT Big Bore was found to be out of tolerance for radio frequency emissions. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall HydroFinity Hydrophilic guidewire Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2014ClassClass IStatusTerminatedWhereNationwide
- Medical device recall HydroFinity Hydrophilic guidewire Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2014ClassClass IStatusTerminatedWhereNationwide
- Medical device recall HydroFinity Hydrophilic guidewire Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2014ClassClass IStatusTerminatedWhereNationwide
- Medical device recall HydroFinity Hydrophilic guidewire Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2014ClassClass IStatusTerminatedWhereNationwide
- Medical device recall HydroFinity Hydrophilic guidewire Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2014ClassClass IStatusTerminatedWhereNationwide
- Medical device recall HydroFinity Hydrophilic guidewire Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2014ClassClass IStatusTerminatedWhereNationwide
- Medical device recall HydroFinity Hydrophilic guidewire Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2014ClassClass IStatusTerminatedWhereNationwide
- Medical device recall HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft,… Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2014ClassClass IStatusTerminatedWhereNationwide
- Medical device recall HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft,… Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2014ClassClass IStatusTerminatedWhereNationwide
- Medical device recall HydroFinity Hydrophilic guidewire Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2014ClassClass IStatusTerminatedWhereNationwide
- Medical device recall HydroFinity Hydrophilic guidewire Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2014ClassClass IStatusTerminatedWhereNationwide
- Medical device recall HydroFinity Hydrophilic guidewire Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2014ClassClass IStatusTerminatedWhereNationwide
- Medical device recall UniCel DxH 800 Coulter Cellular Analysis System Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in… Class IIFDA’s classJul 2, 2014in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedJul 2, 2014ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall UniCel DxH 600 Coulter Cellular Analysis System Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in… Class IIFDA’s classJul 2, 2014in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedJul 2, 2014ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Coulter DxH Cleaner 5L Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in… Class IIFDA’s classJul 2, 2014in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedJul 2, 2014ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Coulter DxH Cleaner 10L Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in… Class IIFDA’s classJul 2, 2014in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedJul 2, 2014ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Siemens LANTIS System There is a potential risk when using LANTIS OIS System client software with operating systems for which it has not been validated and released, resulting in… Class IIFDA’s classJul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Integra UCR 3mm Hex, Large Axial Driver Integra has identified through an investigation of complaints that there may be the potential for the tip of a single lot number of the UCR 3mm Hex, Large… Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, New Mexico, Ohio and Tennessee
- Medical device recall VerSys¿ Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw During routine inspection, beaded hip stem forgings received from supplier failed to meet ZES 2A-102. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Massachusetts, Michigan, Minnesota, North Carolina, North Dakota, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Virginia and Wisconsin 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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