Medical devices, 2015
Shortlist up to four to read them side by side.
2,495 medical device recalls FDA’s Enforcement Report published in 2015, 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.
2,495of 2,495 medical device recallsshown with your filters
The list
- Medical device recall Synthes Small Notch Titanium Reconstructive Plate set (SNTRP) The Synthes SNTRP set was released for sale as a Trauma product in 1996 with specific trauma indications and contraindicated for certain spine applications. Class IIFDA’s classNov 18, 2015in FDA’s Enforcement Report18 statesnamed in where it went PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Florida, Indiana, Louisiana, Minnesota, Missouri, Mississippi, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Virginia, Vermont and Washington
- Medical device recall TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses Tekia is recalling the Single Piece Hydrophillic Acrylic Intraocular Lenses (IOLs) because they may be labeled with the incorrect diopter power. Class IIFDA’s classNov 18, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA IgM kit because of the potential increase in invalid results. Class IIFDA’s classNov 18, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Access CEA Assay Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly. Class IIFDA’s classNov 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution Custom Sterile Surgical kits contain 3M DuraPrep (TM) Surgical Solution, Catalog Number 8630, Lot Number 2016-09EE which was recalled due to unintended… Class IIFDA’s classNov 18, 2015in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereArkansas, Florida, Minnesota, New Jersey, Ohio, Oklahoma and South Carolina
- Medical device recall DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution Custom Sterile Surgical kits contain 3M DuraPrep (TM) Surgical Solution, Catalog Number 8630, Lot Number 2016-09EE which was recalled due to unintended… Class IIFDA’s classNov 18, 2015in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereArkansas, Florida, Minnesota, New Jersey, Ohio, Oklahoma and South Carolina
- Medical device recall Triton Infusion Pump (model 300000) and Triton fp Infusion Pump (model 400000) (proprietary name: AFF (Mark… The device might fail to detect air in line while infusing the medication Venofer. Class IIFDA’s classNov 18, 2015in FDA’s Enforcement Report22 statesnamed in where it went PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Delaware, Florida, Georgia, Illinois, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, Tennessee, Texas and Washington
- Medical device recall Amphirion Deep OTW PTA Balloon Catheter Medtronic has discovered that select lots of the Amphirion Deep PTA Balloon Dilation Catheter have a potential breach in the pouch seal enclosing the… Class IIFDA’s classNov 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use. Cook Medical has received six product complaints associated with reports of the 2.6FR curved catheter being mixed with the 4.0FR straight catheter and vice… Class IIFDA’s classNov 18, 2015in FDA’s Enforcement Report10 statesnamed in where it went PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereCalifornia, Florida, Idaho, Illinois, Massachusetts, New York, Oklahoma, Texas, Utah and Virginia
- Medical device recall R¿sch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip, Sterile Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet. Class IIFDA’s classNov 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Rusch Flexi-slip tracheal tube Stylet, Size Ch 6, Sterile, Teleflex Medical. Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet. Class IIFDA’s classNov 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge Group, Adjustable Positioning Elements Two serious thromboembolic events were reported involving the Adjustable Positioning Elements (Part Number 1007.28A0) in conjunction with Universal Frame (Part… Class IIFDA’s classNov 18, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereAlabama, California and Missouri
- Medical device recall Maquet Getinge Group, Universal Frame for Positioning Patients Two serious thromboembolic events were reported involving the Adjustable Positioning Elements (Part Number 1007.28A0) in conjunction with Universal Frame (Part… Class IIFDA’s classNov 18, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereAlabama, California and Missouri
- Medical device recall Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS Stryker is recalling various lots of the Trithion MIS Modular Distal Capture because complaints were received that specific lots of this product may… Class IIFDA’s classNov 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Delaware, Idaho, Illinois, Kansas, Louisiana, Michigan, New Hampshire, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Texas, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall NovoCut Suture Manager The NovoCut Suture Manager device may cut the suture during knot tensioning and this may cause the suture knot to unravel. Class IIFDA’s classNov 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Shimadzu C-arm Table The C-arm may interfere with the table top under certain circumstances. Class IIFDA’s classNov 18, 2015in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereConnecticut, Ohio, Texas and Wisconsin
- Medical device recall Smooth Muscle Action (SMA) Immunohistochemistry reagent Certain catalog numbers and lots of Smooth Muscle Actin may stain some cell types that are typically expected to be negative for SMA. Class IIFDA’s classNov 18, 2015in FDA’s Enforcement Report23 statesnamed in where it went PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas and Utah
- Medical device recall MILEX PESSARY KIT The products have been identified to have incorrect size prints on the MILEX PESSARY KIT packaging. Class IIIFDA’s classNov 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedNov 18, 2015ClassClass IIIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Montana, North Carolina, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Dakota, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall GE Healthcare, Discovery MR750w 3.0T When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. Class IIFDA’s classNov 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named
- Medical device recall GE Healthcare, SIGNA 3.0T When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. Class IIFDA’s classNov 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named
- Medical device recall GE Healthcare, SIGNA Excite 3.0T When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. Class IIFDA’s classNov 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named
- Medical device recall GE Healthcare, SIGNA HD 3.0T When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. Class IIFDA’s classNov 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named
- Medical device recall GE Healthcare, SIGNA HDx 3.0T When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. Class IIFDA’s classNov 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named
- Medical device recall GE Healthcare, SIGNA HDxt 3.0T When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. Class IIFDA’s classNov 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named
- Medical device recall GE Healthcare, SIGNA PET/MR 3.0T When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. Class IIFDA’s classNov 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named
- Medical device recall Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads Complaints that the femoral head could not be assembled with its corresponding V40 stem trunnion at the time of surgery. Class IIFDA’s classNov 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, M3536MC, M3536M4, M3536M5 The… MRx Defib can be susceptible to one or both issues: 1. Class IIFDA’s classNov 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy. When the system is driving over a non-conductive floor and then over a conductive, grounded part, proper control of the drive behavior may not be possible. Class IIFDA’s classNov 18, 2015in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereMassachusetts, Missouri, North Carolina and Ohio
- Medical device recall CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans Monitor may shut down unintentionally without restarting. Class IIFDA’s classNov 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MODULARIS VARIOSTAR Display freeze of MODULARIS hand control results in information not being updated on the display. Class IIFDA’s classNov 18, 2015in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereGeorgia, Kentucky, Louisiana, Missouri, Mississippi, North Carolina and Puerto Rico
- Medical device recall Biomet 3i Narrow Right Angle Large Driver Tip (Hexed) The RASH3N, a hexed, abutment screw driver tip has been labeled and distributed as RASQ3N, a square, abutment screw driver tip. Class IIFDA’s classNov 18, 2015in FDA’s Enforcement Report30 statesnamed in where it went PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereAlaska, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia and Washington
- Medical device recall Biomet 3i Narrow Right Angle Square Driver Tip RASQ3N, a square, abutment screw driver tip has been labeled and distributed as RASH3N, a hexed, abutment screw driver tip. Class IIFDA’s classNov 18, 2015in FDA’s Enforcement Report30 statesnamed in where it went PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereAlaska, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia and Washington
- Medical device recall Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Sterilized using Ethylene Oxide This recall is being initiated due to a potential breach of the Tubing Pack Header Bags manufactured in these select lots. Class IIFDA’s classNov 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Illinois, Indiana and Wisconsin named
- Medical device recall Ventilator Tubing As a distributor of tubing manufactured by Smooth Bore Plastics, we are initiating a product recall for specific lots of KC 036, KC 060 and KC 072 reusable… Class IIFDA’s classNov 18, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Ohio, Pennsylvania and Washington
- Medical device recall Stryker Radius 5.5 to 3.5 Rod to Red Connector Stryker Spine is recalling Radius Rod to Rod Connector 5.5 to 3.5 mm (Catalog #486614530) because it does not have an associated 510(k) submisstion and… Class IIFDA’s classNov 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Washington and Wisconsin named
- Medical device recall HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31 Ventilation and alarms of a HAMILTON-G5 ventilator can be suppressed unintentionally after the activation of a suctioning maneuver by the operator; this… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2015ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path Leakage from the inlet port of the 15L Cycler Drainage Bags. Class IIFDA’s classNov 11, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 11, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Custom Pak 9319-27 The recalled lot of custom paks are labeled as latex free and contain latex gloves rather than the specified non-latex gloves. Class IIFDA’s classNov 11, 2015in FDA’s Enforcement ReportVermontthe one state its words name PublishedNov 11, 2015ClassClass IIStatusTerminatedWhereVermont
- Medical device recall MR Surgical Suite II Table GE became aware of an issue with the table transfer release mechanism of the MR Surgical Suite Option. Class IIFDA’s classNov 11, 2015in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 11, 2015ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Illinois, Michigan, Ohio, Texas and Wisconsin
- Medical device recall GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile installations that combines Positron… The reason for this inspection is to determine if the Spindle Block Servo Controllers on the CT subsystem of potentially affected GEMINI PET/CT systems are… Class IIFDA’s classNov 11, 2015in FDA’s Enforcement Report35 statesnamed in where it went PublishedNov 11, 2015ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Missouri, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Antibacterial Hydro Personal Catheter, Male 12 Fr Incorrect unit labeling. Class IIIFDA’s classNov 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedNov 11, 2015ClassClass IIIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Missouri, New Jersey, Oregon, Pennsylvania, Texas and Washington named
- Medical device recall Robotic hand accessory to InMotion Arm, rehabilitation robot. Unsupervised patient could potentially mis-use the device and remove or rotate a protective cover and expose a potential pinch hazard. Class IIFDA’s classNov 11, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 11, 2015ClassClass IIStatusTerminatedWhereTennessee and Texas
- Medical device recall Medtronic Achieve Cables 64 units of Achieve Electrical Cables were shipped with a potential sterility breach. Class IIFDA’s classNov 11, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedNov 11, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Delaware, Georgia, Iowa, Kentucky, Maine, Michigan, Minnesota, New York, Ohio, Pennsylvania, Tennessee, Texas and Virginia
- Medical device recall Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant… Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating. Class IIFDA’s classNov 11, 2015in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 11, 2015ClassClass IIStatusTerminatedWhereArizona, Colorado, Florida and Maryland
- Medical device recall VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL The firm is conducting a product correction due to an increase in U90-382 or 6LU condition codes (wash errors) when using VITROS Calibrator Kit 9, Lot 0954. Class IIIFDA’s classNov 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 11, 2015ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter screws. Class IIFDA’s classNov 11, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 11, 2015ClassClass IIStatusTerminatedWhereFlorida, Missouri and New York
- Medical device recall Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A 1. Class IIFDA’s classNov 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arthroscopic Energy 50¿ Probe with Suction Probe programming error. Class IIFDA’s classNov 11, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 11, 2015ClassClass IIStatusTerminatedWhereFlorida and Ohio
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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