Medical devices, 2013
Shortlist up to four to read them side by side.
2,249 medical device recalls FDA’s Enforcement Report published in 2013, 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.
2,249of 2,249 medical device recallsshown with your filters
The list
- Medical device recall Stryker Howmedica Osteonics Corp Stryker Orthopaedics has received a report indicating that the scale of the AxSOS Calibrated Drill Bit 4.3,,X263mm, flat , manufactured by Stryker… Class IIFDA’s classMay 8, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedMay 8, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Missouri, Montana, North Carolina, New Jersey, New Mexico, Tennessee, Texas and Virginia named
- Medical device recall MSK EXTREME MR SCANNER Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard. Class IIFDA’s classMay 8, 2013in FDA’s Enforcement Report20 statesnamed in where it went PublishedMay 8, 2013ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Florida, Idaho, Illinois, Massachusetts, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Optima MR430s MRI Scanner Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard. Class IIFDA’s classMay 8, 2013in FDA’s Enforcement Report20 statesnamed in where it went PublishedMay 8, 2013ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Florida, Idaho, Illinois, Massachusetts, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall 3DKnee e+ Tibial Insert U.S. Class IIFDA’s classMay 8, 2013in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedMay 8, 2013ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall NxStage PureFlow-B Solution Product may be mislabeled. Class IIFDA’s classMay 8, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedMay 8, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Florida, Illinois, New York, South Carolina, Texas and Virginia named
- Medical device recall Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long Term Monitoring system (Models HSYS-REC-WD,… The firm is initiating this recall because the implied or stated indications in their labeling associated with Harmonie software have not yet been cleared by… Class IIFDA’s classMay 1, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Delaware, Florida, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia, Vermont, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Chemistry Products PHBR (Phenobarbital) Slides Ortho Clinical Diagnostics (OCD) received customer complaints of intermittent imprecision, outliers, or shifts in accuracy and control fluid values outside of… Class IIFDA’s classMay 1, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Glucose test strips reports no result message when tested Class IIFDA’s classMay 1, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Kentucky, New York and West Virginia named
- Medical device recall Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Glucose test strips reports no result message when tested Class IIFDA’s classMay 1, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Kentucky, New York and West Virginia named
- Medical device recall RoboCouch Patient Positioning System Product Usage: is intended for use in the support and positioning of a… A5 gearboxes responsible for pitch (head up and head down) and roll (patient left and right) motions of the RoboCouch manipulator may be defective. Class IIFDA’s classMay 1, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Missouri, Ohio, Oklahoma and Virginia named
- Medical device recall Orthopedic Alliance Spine System (alias “Blue & Gold”) Orthopedic Alliance is recalling Blue & Gold Implants and Instruments because the Blue & Gold system is not supported by adequate testing and documentation to… Class IIFDA’s classMay 1, 2013in FDA’s Enforcement ReportTexasthe one state its words name PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereTexas
- Medical device recall APLIF Implants and Instruments Spinal Solutions is recalling the APLIF system because it is not supported by adequate testing and documentation to demonstrate that it meets performance or… Class IIFDA’s classMay 1, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Maryland, Nevada and Wisconsin named
- Medical device recall Belly Bag Urine Collection Bag with Hip Belt Sterile packaging may be compromised. Class IIFDA’s classMay 1, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall VITROS¿ Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B surface antigen (anti-HBs)) Reagent… Ortho Clinical Diagnostics is recalling certain lots of the Vitros Anti-HBs Reagent packs an inability to obtain a valid calibration. Class IIIFDA’s classMay 1, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 1, 2013ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall Sirtex SIR-yttrium 90 microspheres (Radionuclide) Incorrect expiration date Class IIIFDA’s classMay 1, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedMay 1, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, District of Columbia, Georgia, Idaho, Illinois, Kentucky, Louisiana, Maryland, Maine, Missouri, Montana, New Jersey, Nevada, Washington and West Virginia named
- Medical device recall Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option Varian has identified an anomaly with the RPM Respiratory Gating System version I.7.5 with 3D Option. Class IIFDA’s classMay 1, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GE Healthcare, Xeleris 2 Processing & Review Workstation GE Healthcare has become aware of a software issue in your Xeleris 2.1 workstation (that is used for processing Discovery 530/570 data), that may impact… Class IIFDA’s classMay 1, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereGeorgia and New York
- Medical device recall NeuViz 16 Multi-Slice CT Scanner System User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. Class IIFDA’s classMay 1, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, North Carolina, Nebraska, Ohio, Puerto Rico, South Carolina and Texas named
- Medical device recall NeuViz Dual series CT Scanner System User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. Class IIFDA’s classMay 1, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, North Carolina, Nebraska, Ohio, Puerto Rico, South Carolina and Texas named
- Medical device recall AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated… Beckman Coulter, Inc. Class IIFDA’s classMay 1, 2013in FDA’s Enforcement Report18 statesnamed in where it went PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Illinois, Indiana, Kansas, Massachusetts, Michigan, North Carolina, New Jersey, Nevada, New York, Ohio, Pennsylvania, Puerto Rico, Texas, Utah, Virginia and Wisconsin
- Medical device recall Ventri Discovery NM 530c, Ventri with Premium Table Discovery NM 530c, models H3000ZW & H3000SA GE Healthcare has recently become aware of an incident which caused a patient injury during an unload following an exam on a Ventri scanner. Class IIFDA’s classMay 1, 2013in FDA’s Enforcement Report40 statesnamed in where it went PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. Class IIFDA’s classMay 1, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ORTHOCORD ONE VIOLET AND ONE BLUE BRAIDED COMPOSITE SUTURE 2 The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. Class IIFDA’s classMay 1, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-7 Taper Needles The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. Class IIFDA’s classMay 1, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-6 Taper Needles The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. Class IIFDA’s classMay 1, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ORTHOCORD One Violet and One Blue Braided Composite Suture with OS-6 Reverse Cutting Needles The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. Class IIFDA’s classMay 1, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) Test Cassette The Alere Cholestech LDX¿ hsCRP cassette (PN 12-807) may have increased imprecision relative to the performance data in the package insert, which may cause… Class IIFDA’s classMay 1, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips Healthcare Computed Tomography X-Ray System Philips Healthcare discovered the customer was performing CTDI measurements for facility accreditation and received results that were 15 to 25% higher than… Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DeGotzen XRay unit XGenus Dental X-ray unit. It was discovered at the WEAC Labs method sample did not meet requirements for labeling and certification Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended to be used as… With regards to ShapeMatch Cutting Guides using MRI Imaging, Stryker Orthopaedics has become aware that there are potential issues associated with internal… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall All OneTouch Verio IQ Blood Glucose Meters The Verio IQ meter will shut off and revert to set up mode at glucose values above 1023 instead of displaying EXTREME HIGH GLUCOSE. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Alaris PC unit The recall was initiated because Carefusion has received reports of a communication error on the Alaris PC unit model 8015 with software version 9.12 when the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., IntelliSpace Portal (ISP) is a… Philips was notified of a problem using the IntelliSpace Portal with software version 4.0.2 with the URL PACS integration. Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Florida, Georgia, Iowa, Indiana, Louisiana, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall Integra XKnife¿ Stereotactic Radiosurgery and Radiotherapy Treatment Planning, Software Versions 5.0.1 and… Depending on the system configuration, a software error message in versions 5.0.1 and 5.0.2. Class IIFDA’s classApr 24, 2013in FDA’s Enforcement Report9 statesnamed in where it went PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereIdaho, Illinois, Louisiana, Massachusetts, New Jersey, New York, Ohio, Pennsylvania and South Dakota
- Medical device recall Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300) Toshiba Medical Systems has received reports of startup issues with the Toshiba TUS-500 and TUS-300 ultrasound systems. Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens syngo WorkFlow SLR, Radiological Information System, Version VA31A SP1/SP2/SP3 The information system… Under certain conditions, when using the Search functionality, the potential exists for the wrong patient’s Interactive Documents to display when viewing a… Class IIFDA’s classApr 24, 2013in FDA’s Enforcement Report31 statesnamed in where it went PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Wisconsin, West Virginia and Wyoming
- Medical device recall VITROS 5,1 FS Chemistry System Ortho-Clinical Diagnostics, Inc. Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VITROS 4600 Chemistry System (VITROS 5,1 FS System family member) Ortho-Clinical Diagnostics, Inc. Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VITROS 5600 Integrated System Ortho-Clinical Diagnostics, Inc. Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information regarding sterile adapter engagement and instrument… Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da Vinci Si-e Surgical System Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information regarding sterile adapter engagement and instrument… Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Edwards Lifesciences Duraflo coated Femoral Cannula Two unsealed pouches were found at an Edwards’ distribution location in Japan. Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide, and Florida, Massachusetts, Michigan, New York, Pennsylvania and Texas named
- Medical device recall Alaris PC unit The recall was initiated because Carefusion has identified potential risk associated with bolus programming with the Alaris PC unit (model 8015) software… Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode reading meters had the potential of intermittent erroneous… Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode reading meters had the potential of intermittent erroneous… Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) &… Various reciprocating and oscillating saw blades were incorrectly labeled. Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in… During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion. Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in… During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion. Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide
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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