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 5, 2026.
3,059of 3,059 medical device recallsshown with your filters
The list
- Medical device recall PKG, 3MM INSERT, FUNDUS GRASPER, 29CM, P/N 0250282050 Laparoscopic Manual Instruments are intended for… The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, 3MM INSERT, FUNDUS GRASPER, 29CPKG, 3MM INSERT, ALLIGATOR GRASPER, 29CM, P/N 0250282051 Laparoscopic… The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, 3MM INSERT, NEEDLE NOSE FORCEPS, 29CM, P/N 0250282052 Laparoscopic Manual Instruments are intended for… The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, 3MM INSERT, SCHERTL GRASPER, FENESTRATED, 29CM, P/N 0250282053 Laparoscopic Manual Instruments are… The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, 3MM INSERT, BLUNT WITH SPOON, GRASPER, 29CM, P/N 0250282055 Laparoscopic Manual Instruments are intended… The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, 3MM INSERT, BLUNT GRASPER, 29CM, P/N 0250282056 Laparoscopic Manual Instruments are intended for… The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, 3MM INSERT, BULLET FORCEPS, 29CM, P/N 0250282057 Laparoscopic Manual Instruments are intended for… The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, 3MM INSERT, MARYLAND, FORCEPS CURVED, 29CM, P/N 0250282058 Laparoscopic Manual Instruments are intended… The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, 3MM INSERT, BIOPSY FORCEPS, 29CM, P/N 0250282059 Laparoscopic Manual Instruments are intended for… The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, 3MM INSERT, BIOPSY PUNCH, 29CM, P/N 0250282060 Laparoscopic Manual Instruments are intended for cutting,… The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, 3MM INSERT, STRAIGHT NEEDLEHOLDER, 29CM, P/N 0250282061 Laparoscopic Manual Instruments are intended for… The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, 3MM INSERT, DORSEY GRASPER, 20CM, P/N 0250282096 Laparoscopic Manual Instruments are intended for… The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, 3MM INSERT, DORSEY GRASPER, 29CM, P/N 0250282097 Laparoscopic Manual Instruments are intended for… The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, 3MM INSERT, ATRAUMATIC GRASPER, SINGLE ACTION, 29CM, P/N 0250282099 Laparoscopic Manual Instruments are… The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, 3MM INSERT, ATRAUMATIC GRASPER, DOUBLE ACTION, 20CM, P/N 0250282100 Laparoscopic Manual Instruments are… The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, 3MM INSERT, ATRAUMATIC GRASPER, DOUBLE ACTION, 29CM, P/N 0250282101 Laparoscopic Manual Instruments are… Stryker Endoscopy is recalling Laparoscopic manual instruments and accessories because the parameters provided in the Laparoscopic Manual Instruments… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG., 3MM INSERT, BABCOCK FORCEPS, 29CM, P/N 0250282103 Laparoscopic Manual Instruments are intended for… Stryker Endoscopy is recalling Laparoscopic manual instruments and accessories because the parameters provided in the Laparoscopic Manual Instruments… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, 3MM X 20CM INSERT, RIGHT ANGLE DISSECTOR, LONG JAW, P/N 0250282104 Laparoscopic Manual Instruments are… Stryker Endoscopy is recalling Laparoscopic manual instruments and accessories because the parameters provided in the Laparoscopic Manual Instruments… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, 3MM X 29CM INSERT, RIGHT ANGLE DISSECTOR, LONG JAW, P/N 0250282105 Laparoscopic Manual Instruments are… Stryker Endoscopy is recalling Laparoscopic manual instruments and accessories because the parameters provided in the Laparoscopic Manual Instruments… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, 3MM X 29CM INSERT, DISSECTING FORCEPS, P/N 0250282110 Laparoscopic Manual Instruments are intended for… Stryker Endoscopy is recalling Laparoscopic manual instruments and accessories because the parameters provided in the Laparoscopic Manual Instruments… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, CANNULA 8MM AUTOMATIC VALVE STOP COCK, W/O TROCAR, P/N 0250080172 Laparoscopic Manual Instruments are… Stryker Endoscopy is recalling Laparoscopic manual instruments and accessories because the parameters provided in the Laparoscopic Manual Instruments… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sheridan/CF Cuffed Tracheal Tube, Sterile Product Labeling; Units from the affected lot indicates that it contains a size 8mm tracheal tube but may contain a size 7.5mm tracheal tube. Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall DRX-Revolution Mobile X-Ray System While servicing a unit at a customer site, a field engineer discovered a broken bolt from the carriage assembly. Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum,… Recalled by FDA on Dec 24, 2014 Class IIFDA’s classDec 24, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereColorado, Florida, Minnesota, Montana and New York
- Medical device recall Specialty Audible Torque Wrench Mfg by: Stryker Spine Stryker has received a complaint from customers relating to a fracture during the use of the Specialty Audible Torque Wrench in surgery. Class IIFDA’s classDec 24, 2014in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereGeorgia, Indiana, Michigan, New Jersey, Ohio, Pennsylvania, Texas and Virginia
- Medical device recall Radiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Radiomat M+ NIF 10 x 12, Radiomat M+ NIF 25,4CM x 30,5CM Some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin line when the film is processed. Class IIIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedDec 24, 2014ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Louisiana, Michigan, North Carolina, Nebraska, New Hampshire, New Jersey and Virginia named
- Medical device recall AMS Monarc + Subfascial Hammock with Tensioning Suture During routine periodic packaging testing, AMS identified that in simulated extreme shipping and handling situations the sterile barrier packaging of the… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall AdVance”Male Sling System During routine periodic packaging testing, AMS identified that in simulated extreme shipping and handling situations the sterile barrier packaging of the… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Biograph mCT Flow Edge-4R, System Material Number 10528955 Possibility for system display freeze during CT interventional procedures. Class IIFDA’s classDec 24, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereMassachusetts and North Carolina
- Medical device recall Biograph mCT Flow 40-4R, System Material Number 10529159 Possibility for system display freeze during CT interventional procedures. Class IIFDA’s classDec 24, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereMassachusetts and North Carolina
- Medical device recall Biograph mCT X-4R, System Material Number 10248670 Possibility for system display freeze during CT interventional procedures. Class IIFDA’s classDec 24, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereMassachusetts and North Carolina
- Medical device recall Biograph mCT S(64)-4R, System Material Number 10248672 Possibility for system display freeze during CT interventional procedures. Class IIFDA’s classDec 24, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereMassachusetts and North Carolina
- Medical device recall Biograph mCT S(40)-4R, System Material Number 10248671 Possibility for system display freeze during CT interventional procedures. Class IIFDA’s classDec 24, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereMassachusetts and North Carolina
- Medical device recall ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 12 degrees… Product is mislabeled. Class IIFDA’s classDec 24, 2014in FDA’s Enforcement Report6 statesnamed in where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Illinois, Maryland, Montana and Texas
- Medical device recall Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint between the first… Integra LifeSciences has determined that a portion of some specific lots of size 10 PyroSphere CMC and PyroSphere TMT devices are non-radiopaque. Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportWashingtonthe one state its words name PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereWashington
- Medical device recall Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to shunt cerebrospinal… Aesculap Inc. Class IIIFDA’s classDec 24, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 24, 2014ClassClass IIIStatusTerminatedWhereOklahoma and Wisconsin
- Medical device recall Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins… When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) applications, the reported End-Systolic Volume (ESV) may be… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement Report32 statesnamed in where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereAlaska, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall EPIQ 5 Ultrasound System, EPIQ 5 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ… When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) applications, the reported End-Systolic Volume (ESV) may be… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement Report32 statesnamed in where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereAlaska, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall EPIQ 7 Ultrasound System, EPIQ 7 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ… When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) applications, the reported End-Systolic Volume (ESV) may be… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement Report32 statesnamed in where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereAlaska, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall Q-Station Quantification Software When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) applications, the reported End-Systolic Volume (ESV) may be… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement Report32 statesnamed in where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereAlaska, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96… Through in-house routine real time stability monitoring of Trinity’s Captia Syphilis IgM Capture Test Kit, Lot 033, the firm identified a failure of the kit to… Class IIIFDA’s classDec 24, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 24, 2014ClassClass IIIStatusTerminatedWhereCalifornia, Florida, New York and Utah
- Medical device recall CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and… Reduced mammographic image quality when attempting to print true size multi-format images Class IIFDA’s classDec 24, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNorth Carolina, New York and Ohio
- Medical device recall VERO Linear Accelerator System Software Anomaly. Class IIFDA’s classDec 24, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereFlorida, New York, Ohio and Texas
- Medical device recall Device Brand Name: Sirius Polish Cemented Stem 34B Device Classification Name: prosthesis, hip,… After receiving a complaint, Biomet Orthopedic Inc., conducted an investigation which determined that the following parts were mixed up prior to packaging and… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Sirius Polish Cemented Stem 38C After receiving a complaint, Biomet Orthopedic Inc., conducted an investigation which determined that the following parts were mixed up prior to packaging and… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Bone Screw, self-tapping The Trilogy shells are available in three configurations Analysis of returned complaint devices, product in inventory, and device manufacturing records has identified tool marks isolated to one specific machining… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ceramic Femoral Head Two complaints reported that the BIOLOX delta TS Ceramic Femoral Articul/eze12/14 36mm +12 Head (product code 1365-36-740) did not fit like the trial; the… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereAlabama, Arizona and West Virginia
- Medical device recall WECK Hemoclip¿ Traditional Medium Tantalum Ligating Clips The manufacturing dates and expiration dates were transposed on the Tyvek label. Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Delaware, Florida, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Minnesota, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Vermont and Washington 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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