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 Galt trephines are bone cutting and drilling instruments that are used without a power source on a patient’s… The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and… Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall Gardner-Wells traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine… The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and… Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall Replacement screw non-springloaded traction tongs are skull tongs for traction used to immobilize a patient… The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and… Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall Lock nuts for titanium traction tongs are used in traction skull tongs for traction used to immobilize a… The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and… Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall Titanium fixation screws, springloaded are used in traction skull tongs for traction used to immobilize a… The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and… Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall Traction tong replacement screws, non-springloaded are used in traction skull tongs for traction used to… The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and… Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall Gardner-Wells wrenches are used in traction skull tongs for traction used to immobilize a patient with a… The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and… Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall CVB distraction screws are bone cutting and drilling instruments that are used without a power source on a… The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and… Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall Cloward Spanner gauges are bone cutting and drilling instruments that are used without a power source on a… The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and… Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall Tonometers are manual devices intended to measure intraocular pressure by applying a known force on the globe… The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and… Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall Schoitz weights are manual devices used with Schoitz tonometers and are intended to measure intraocular… The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and… Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall Rapid Centesis Catheter, 5 Fr x 7 cm Catheter PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Louisiana, Massachusetts, North Carolina, Ohio, Pennsylvania, Texas and Utah named
- Medical device recall ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Louisiana, Massachusetts, North Carolina, Ohio, Pennsylvania, Texas and Utah named
- Medical device recall ASEPT 600 ml Drainage Kit PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Louisiana, Massachusetts, North Carolina, Ohio, Pennsylvania, Texas and Utah named
- Medical device recall Micro Introducer Kit, 5F Micro Introducer Kit PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Louisiana, Massachusetts, North Carolina, Ohio, Pennsylvania, Texas and Utah named
- Medical device recall 6F x 60 cm Dual Lumen CT PICC PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Louisiana, Massachusetts, North Carolina, Ohio, Pennsylvania, Texas and Utah named
- Medical device recall ASEPT Peritoneal Drainage System PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Louisiana, Massachusetts, North Carolina, Ohio, Pennsylvania, Texas and Utah named
- Medical device recall Thoracentesis & Paracentesis Procedure Tray PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Louisiana, Massachusetts, North Carolina, Ohio, Pennsylvania, Texas and Utah named
- Medical device recall Veta Peritoneal Catheter Kit, Curled PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Louisiana, Massachusetts, North Carolina, Ohio, Pennsylvania, Texas and Utah named
- Medical device recall ASEPT 2000 ml Drainage Bag PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Louisiana, Massachusetts, North Carolina, Ohio, Pennsylvania, Texas and Utah named
- Medical device recall 1488 HD 3-Chip Camera In certain operating room environments, a colored screen image occurs with the 1488 Cameras that were manufactured during a specific time period Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 1488 HD 3-Chip Inline Camera In certain operating room environments, a colored screen image occurs with the 1488 Cameras that were manufactured during a specific time period Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 1488 HD 3-Chip Camera In certain operating room environments, a colored screen image occurs with the 1488 Cameras that were manufactured during a specific time period Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Insyte Autoguard Catheter An active safety engineered peripheral IV catheter with a retracting needle to… BD Insyte Autoguard may have potential damage along the body of the catheter. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Arrow Nerve Block Component Arrow is recalling certain lots of the Continuous Nerve Block Component, Product Code: AB-18040-N, due to a labeling inconsistency. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer Title 2 Bone Screw Remover Instrument Possibility of the weld to the quick-connect breaking when force is applied to the handle for pedicle screw removal. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall INOMAX DSIR Nitric Oxide delivery system An issue has been identified in the INOmax DSIR system that could result in monitored Nitric Oxide (NO) concentration reporting lower than expected. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 17, 2014ClassClass IIStatusTerminatedWherePennsylvania and Virginia
- Medical device recall Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS : Product Usage: Syngo.plaza is a Picture Archiving and… Printouts may be printed in incorrect anatomical size when using syngo.plaza or syngo Imaging XS filming application in conjunction with a printer not released… Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Invacare Perfecto 2 V Oxygen Concentrator The finished device is It was determined that a defective sieve bed subassembly enabled zeolite sieve dust from the sieve beds to migrate into the valves of the manifold assembly and… Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Oxoid Legionella BCYE Growth Supplement Use of the product could result in inadequate recovery of Legionella pneumophila which could result in false negative reporting. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Florida named
- Medical device recall Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switches and Potential breach of sterile barrier due to defective product tray. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IntellaMap Orion High Resolution Mapping Catheter Some IntellaMap Orion High Resolution Mapping Catheters are exhibiting a failure mode in which a glue bond on the Deployment Interlock Button has been observed… Class IIFDA’s classDec 17, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereAlabama, Massachusetts, North Carolina and Oklahoma
- Medical device recall Conformis iTotal CR G2 Knee Replacement System Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportIndianathe one state its words name PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereIndiana
- Medical device recall Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head for degenerative or post-traumatic… Report received where the Align Radial Stem fractured. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Louisiana, Maryland, Maine, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall MEVION S250, used for proton radiation therapy. Software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either pressure or temperature… Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportMissourithe one state its words name PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereMissouri
- Medical device recall LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 4, LEFT The stem taper on this device is undersized; the gauge point is not deep enough. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Iowa, Michigan, Minnesota, Missouri, Ohio, Pennsylvania and Tennessee named
- Medical device recall LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RIGHT The stem taper on this device is undersized; the gauge point is not deep enough. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Iowa, Michigan, Minnesota, Missouri, Ohio, Pennsylvania and Tennessee named
- Medical device recall LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 6, LEFT The stem taper on this device is undersized; the gauge point is not deep enough. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Iowa, Michigan, Minnesota, Missouri, Ohio, Pennsylvania and Tennessee named
- Medical device recall Surgical packs (includes trays, bags and kits) Used by medical staff to perform patient care procedures such… Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Irrigation Tray With Bulb Syringe Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Universal Drainage Tray Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Wound Closure Tray I Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Wound Closure Tray II Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Tracheotomy Care Kit Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Suction Catheter Kit Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Uretheral Catheter Tray Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Surgeon Reinforced Gown XL Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Surgeon Gown Poly Reinforced Lgc Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
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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