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 MOUSE 9732721 STERILE O-ARM 10PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused… Class IIFDA’s classNov 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PACK 9731975 TUMOR RESECTION AXIEM CR Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused… Class IIFDA’s classNov 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused… Class IIFDA’s classNov 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PATIENT TRACKER 9733534XOM ENT 1PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused… Class IIFDA’s classNov 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PIN, 9733235, 100MM, STERILE, PERC REF Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused… Class IIFDA’s classNov 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PIN, 9733236, 150MM, STERILE, PERC REF Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused… Class IIFDA’s classNov 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SHUNT KIT 9733605 NON-INVASIVE Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused… Class IIFDA’s classNov 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SPHERES 8801071 1/TRAY 12PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused… Class IIFDA’s classNov 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SPHERES 8801075 5/TRAY 12PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused… Class IIFDA’s classNov 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TRAJ GUIDE KIT, 9733065, BIOPSY, EXT Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused… Class IIFDA’s classNov 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TRAJ GUIDE KIT, 9733066, BIOPSY, INT Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused… Class IIFDA’s classNov 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TUMOR RES. PACK 9733553 AxiEM S.M. Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused… Class IIFDA’s classNov 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TUMOR RESECTION KIT 9733607 NON-INVASIVE Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused… Class IIFDA’s classNov 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TUMOR RESECTION KIT 9733608 SKULL MOUNT Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused… Class IIFDA’s classNov 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall UPGRD PRGM 9734638 ADD AxiEM NAVIGATION Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused… Class IIFDA’s classNov 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Rapid Neg BP Combo Panel Type 3 An increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Neg Urine Combo Panel Type 1 used with MicroScan Microbiology… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedNov 19, 2014ClassClass IStatusTerminatedWhereNationwide, and California, Florida, Hawaii, Iowa, Illinois, Indiana, Kentucky, Michigan, Mississippi, North Carolina, North Dakota, New Mexico, New York, Ohio, South Dakota, Texas, Utah, Washington, Wisconsin and Wyoming named
- Medical device recall Rapid Neg Urine Combo Panel Type 1 An increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Neg Urine Combo Panel Type 1 used with MicroScan Microbiology… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedNov 19, 2014ClassClass IStatusTerminatedWhereNationwide, and California, Florida, Hawaii, Iowa, Illinois, Indiana, Kentucky, Michigan, Mississippi, North Carolina, North Dakota, New Mexico, New York, Ohio, South Dakota, Texas, Utah, Washington, Wisconsin and Wyoming named
- Medical device recall Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version R8.2.O Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handling was detected, can result in a hazardous movement of the… Class IIFDA’s classNov 19, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 19, 2014ClassClass IIStatusTerminatedWhereIllinois and Tennessee
- Medical device recall Philips Medical Systems Allura Xper FD20C with software version R8.2.O System Code: 722035 Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handling was detected, can result in a hazardous movement of the… Class IIFDA’s classNov 19, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 19, 2014ClassClass IIStatusTerminatedWhereIllinois and Tennessee
- Medical device recall Artis zeego systems A cable inside the C-arm systems may have been routed in an inappropriate manner. Class IIFDA’s classNov 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 19, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye, Infinia II Hawkeye… GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being… Class IIFDA’s classNov 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedNov 19, 2014ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named
- Medical device recall GE Healthcare Varicam/VG and VG Hawkeye devices GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being… Class IIFDA’s classNov 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedNov 19, 2014ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named
- Medical device recall Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being… Class IIFDA’s classNov 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedNov 19, 2014ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named
- Medical device recall Discovery NM 630, dual detector free-geometry integrated nuclear imaging system GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear… Class IIFDA’s classNov 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedNov 19, 2014ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named
- Medical device recall Optima NM/CT 640, Models H3100YA, H3100YC GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being… Class IIFDA’s classNov 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedNov 19, 2014ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named
- Medical device recall Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being… Class IIFDA’s classNov 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedNov 19, 2014ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named
- Medical device recall MX 16-slice CT Scanner System and MX 16-slice CT Scanner System Phase 11 can be used as a whole body computed… "The orientation of images is displayed incorrectly. Class IIFDA’s classNov 19, 2014in FDA’s Enforcement Report20 statesnamed in where it went PublishedNov 19, 2014ClassClass IIStatusOngoingWhereArkansas, California, Florida, Georgia, Illinois, Indiana, Kentucky, Michigan, Mississippi, North Carolina, North Dakota, New Jersey, Nevada, New York, Ohio, Pennsylvania, Puerto Rico, South Carolina, Tennessee and Virginia
- Medical device recall Bard¿ PerFix Light Plug The Bard¿ PerFix Light Plug is indicated for reinforcement if soft tissue, where… The patient record peel-off label product code and size did not match the other labeling and actual product in the packaging for the Bard Small PerFix Light… Class IIFDA’s classNov 19, 2014in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 19, 2014ClassClass IIStatusTerminatedWhereCalifornia, Delaware, Maryland, Minnesota, Missouri, New Mexico, Ohio and Utah
- Medical device recall OEC¿ UroView 2800 GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView… Class IIFDA’s classNov 19, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 19, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall OEC¿ MiniView 6800 GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView… Class IIFDA’s classNov 19, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 19, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall FlexiView 8800 Digital Mobile Imaging System GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView… Class IIFDA’s classNov 19, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 19, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Series OEC 9800 GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView… Class IIFDA’s classNov 19, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 19, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower… The 5085 and 5085SRT stainless steel column shrouds may become damaged as a result of misalignment during extreme table articulation, excessive side force on… Class IIFDA’s classNov 19, 2014in FDA’s Enforcement Report36 statesnamed in where it went PublishedNov 19, 2014ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nevada, New York, Ohio, Oklahoma, Oregon, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Wisconsin and West Virginia
- Medical device recall Integra Titan Reverse Shoulder System right and left head cutting templates, 142.5 degrees A single lot of left and a single lot of right Reverse Shoulder System cutting templates were manufactured incorrectly. Class IIFDA’s classNov 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedNov 19, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Mississippi, Ohio, Tennessee, Texas and Virginia named
- Medical device recall Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is indicated for patients with severe knee… Cleaning process validation failure. Class IIFDA’s classNov 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 19, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ATTUNE Intuition Distal Femoral Jig Issuing a device correction because if the pin bushing is over loaded or inverted, there is the potential for partial or full displacement and fracture of the… Class IIFDA’s classNov 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 19, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Oxoid Legionella BCYE Growth Supplement SR0110A Recalled product may not provide adequate recovery of Legionella pneumophila when used as directed and may result in false negative identification of… Class IIFDA’s classNov 19, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 19, 2014ClassClass IIStatusTerminatedWhereNorth Dakota, Texas and Vermont
- Medical device recall Integra Licox Pt02 Monitor Integra LifeSciences Corporation received 2 complaints that the USB port on the Licox Pt02 monitor does not consistently provide the user the ability to… Class IIFDA’s classNov 19, 2014in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 19, 2014ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Florida, Illinois, Indiana, Michigan, Minnesota, North Carolina, New York, Pennsylvania and Texas
- Medical device recall GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement Medacta has registered in its database 3 cases of breakage of the GMK Intramedullary Extension Rod 100 mm, code 02.07.10.0162. Class IIFDA’s classNov 19, 2014in FDA’s Enforcement ReportOhiothe one state its words name PublishedNov 19, 2014ClassClass IIStatusTerminatedWhereOhio
- Medical device recall Transport Rollator with Padded Seat The caster may separate completely from the device frame causing injury to user. Class IIFDA’s classNov 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedNov 19, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Medtronic Launcher Coronary Guide Catheter Two reports have been received on the 6F launcher Guide Catheter lot (Model Number LA6JR40K; lot No 0007244836} for incorrect usable length of the Guide… Class IIFDA’s classNov 19, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 19, 2014ClassClass IIStatusTerminatedWhereIowa, Illinois, Kansas and North Carolina
- Medical device recall CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Incorrect expiration date printed on the MILEX PESSARY KIT packaging Class IIIFDA’s classNov 19, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedNov 19, 2014ClassClass IIIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Massachusetts, Michigan, Minnesota, New Hampshire, Ohio, Rhode Island, Washington and Wisconsin
- Medical device recall CooperSurgical MILEX PESSARY KITS- Hodge w/Support Folding Pessary- #1 Incorrect expiration date printed on the MILEX PESSARY KIT packaging Class IIIFDA’s classNov 19, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedNov 19, 2014ClassClass IIIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Massachusetts, Michigan, Minnesota, New Hampshire, Ohio, Rhode Island, Washington and Wisconsin
- Medical device recall AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 72401850 AMS’ supplier has issued a recall of certain lots of Lightning Bolt Keith needles supplied in AMS 700 Accessory Kits. Class IIFDA’s classNov 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedNov 19, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New York, Ohio, Oregon, Puerto Rico, Tennessee, Texas, Virginia and Washington named
- Medical device recall Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmer Fisher and Paykel Breakage of the nut that secures the heater head in place, which can cause the heater head to become partially detached and swing towards the bassinet. Class IIFDA’s classNov 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 19, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood… Cardiohelp- i System may have a software issue that can potentially result in an erroneous display of a "Battery Needs Service" message after startup… Class IIFDA’s classNov 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 19, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, IMMULITE 2000 XPi) For in vitro… A typographical error regarding the expiration date was identified in the control module instructions for use. Class IIIFDA’s classNov 19, 2014in FDA’s Enforcement Report9 statesnamed in where it went PublishedNov 19, 2014ClassClass IIIStatusTerminatedWhereCalifornia, Florida, Kentucky, Massachusetts, Minnesota, New York, Pennsylvania, Utah and Virginia
- Medical device recall Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous… Firm has identified a small number of Oximetry Cables with crossed-internal wires. Class IIFDA’s classNov 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 19, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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