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 Synthes Dens Instrument Set (Dens Graphic Case) The Dens Instrument Set has been designed to facilitate the anterior internal fixation of the Dens (odontoid process). Class IIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Vermont, Wisconsin, West Virginia and Wyoming named
- Medical device recall Medtronic Archer Super Stiff Guidewire 0.035 inch Medtronic has identified an issue with a specific lot of the Archer 0.035 inch (0.89mm) Super Stiff Guidewire, model ARCSJ200W, where the PTFE (Teflon) coating… Class IIFDA’s classApr 3, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereFlorida, Minnesota and Ohio
- Medical device recall Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Incorrect size was printed on the outer product packaging. Class IIFDA’s classApr 3, 2013in FDA’s Enforcement Report15 statesnamed in where it went PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereArizona, California, Florida, Massachusetts, Maine, Missouri, Nebraska, New Hampshire, New Mexico, New York, Oklahoma, Pennsylvania, South Carolina, Tennessee and Texas
- Medical device recall Medtronic Archer 0.035 inch Medtronic has identified an issue involving specific lot numbers of the Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W,… Class IIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Microbiologics KWIK-QC SLIDES ( KWIK-QC Acid Fast Stain Slides and KWIK-QC Mycobacterium Slides) Microbiologics Inc is initiating a voluntary recall on products KWIK-QC Acid Fast Stain Slide, SL42-10 and KWIK-QC Mycobacterium, SL43-10. Class IIFDA’s classApr 3, 2013in FDA’s Enforcement Report7 statesnamed in where it went PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereCalifornia, Indiana, Mississippi, New York, Ohio, Pennsylvania and South Dakota
- Medical device recall Gen-Probe LIFECODES PF4 Enhanced assay Lifecodes PF4 Enhanced assay, lot number 3000389, is being recalled because of observed inconsistent replicate values when testing the kit Positive Control and… Class IIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 20-Pole Eco Cable Biosense is recalling the 20-Pole Eco Cable because it was incorrectly calibrated. Class IIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and Delaware named
- Medical device recall Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number 101-00006… The 1.6 mm Guidewire is undersized up to 2 mm in length. Class IIFDA’s classMar 27, 2013in FDA’s Enforcement Report14 statesnamed in where it went PublishedMar 27, 2013ClassClass IIStatusTerminatedWhereArizona, California, Florida, Illinois, Maryland, North Carolina, New Hampshire, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas and Virginia
- Medical device recall Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm A dimensional mismatch was identified which can potentially allow for interference between devices. Class IIFDA’s classMar 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedMar 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Maryland, Minnesota, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Tennessee and Virginia named
- Medical device recall Biomet Spine Polaris 5.5 Button Lock Screw Inserter Increased risk of failure at the driver tip during screw insertion or removal. Class IIFDA’s classMar 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMar 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Indiana, Missouri, Nebraska, Tennessee and Texas named
- Medical device recall Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary bypass Risk that air may be introduced into the device which may lead to an air embolism. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 27, 2013in FDA’s Enforcement Report43 statesnamed in where it went PublishedMar 27, 2013ClassClass IStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate It was discovered that one of the VA-LCP Dorsal Distal Radius Plates was incorrectly etched as Part Number 02.115.431 (110 degree) instead of the correct Part… Class IIFDA’s classMar 27, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedMar 27, 2013ClassClass IIStatusTerminatedWhereIndiana, Ohio, Pennsylvania and Texas
- Medical device recall Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107) Siemens has confirmed customer complaints of low patient sample recovery with Dimension(R) TACR Flex(R) lot FA3085. Class IIFDA’s classMar 27, 2013in FDA’s Enforcement Report20 statesnamed in where it went PublishedMar 27, 2013ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, District of Columbia, Florida, Louisiana, Maryland, Michigan, Missouri, North Carolina, New Jersey, New Mexico, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia and Washington
- Medical device recall Creatinine, Part Numbers OSR6178, OSR6678 Product Usage: System reagent for the quantitative determination of… Beckman Coulter is including additional information and instructions in the Creatinine (OSR6x78) IFU and Setting Sheet, relating to calibration stability and… Class IIFDA’s classMar 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fracture Table Orthopedic Leg Holders,… Some units may have been assembled incorrectly which could result in the boot breaking free from the mounting base and allowing the patient’s leg to fall. Class IIFDA’s classMar 27, 2013in FDA’s Enforcement Report10 statesnamed in where it went PublishedMar 27, 2013ClassClass IIStatusTerminatedWhereAlabama, Georgia, Illinois, Kentucky, Nevada, New York, Ohio, Pennsylvania, Texas and Washington
- Medical device recall DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck Class IIFDA’s classMar 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck Class IIFDA’s classMar 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck Class IIFDA’s classMar 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck Class IIFDA’s classMar 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Howmedica Osteonics Corp The standard Triathlon Femoral Stylus does not fit into the Specialty Sizers and the “R” and “L” markings on the Right Sizer are reversed. Class IIFDA’s classMar 27, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 27, 2013ClassClass IIStatusTerminatedWhereDelaware and New Jersey
- Medical device recall Boston Scientific/Cameron Health SQ-RX An internal protective fuse can be unintentionally activated while the device is charging its capacitors for shock delivery or induction. Class IIFDA’s classMar 27, 2013in FDA’s Enforcement Report17 statesnamed in where it went PublishedMar 27, 2013ClassClass IIStatusTerminatedWhereArizona, California, Colorado, District of Columbia, Georgia, Illinois, Massachusetts, Maryland, Minnesota, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Virginia and Washington
- Medical device recall 20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy… The defect was with mis-engraving of the lot # directly on the product and its packaging. Class IIIFDA’s classMar 27, 2013in FDA’s Enforcement Report6 statesnamed in where it went PublishedMar 27, 2013ClassClass IIIStatusTerminatedWhereArizona, California, Georgia, Minnesota, New Jersey and New Mexico
- Medical device recall ILLICO Straight CP TI Rod, -5.5MM x 110M The rods were incorrectly laser etched as ILLICO¿ Straight CP Tl Rods, 110mm, when they were in fact manufactured to 100mm in length. Class IIFDA’s classMar 27, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 27, 2013ClassClass IIStatusTerminatedWhereColorado and North Carolina
- Medical device recall Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Absorber… A defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and Service Kits may cause a condition leading to an increase in the carbon dioxide… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 27, 2013ClassClass IStatusTerminatedWhereNationwide, and North Carolina and New Mexico named
- Medical device recall Sterile Access & Return Line Set, 36” Length, Part # UM-872-36 The recalled product leaks at the connection site. Class IIFDA’s classMar 27, 2013in FDA’s Enforcement ReportMichiganthe one state its words name PublishedMar 27, 2013ClassClass IIStatusTerminatedWhereMichigan
- Medical device recall CR MD1.0 General Set, x-ray imager image plate The cassettes were shipped with the wrong IP (image plate) size bar code. Class IIFDA’s classMar 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedMar 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Indiana, Minnesota, Nebraska, Nevada, Ohio, South Carolina and Utah named
- Medical device recall Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques: Sigma HP Instruments Classic Surgical… Potential for the IM rod to break, leaving fragments in the patient. Class IIFDA’s classMar 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ReClaim Reamer Extension The tabs on the reamer extension device have broken. Class IIFDA’s classMar 27, 2013in FDA’s Enforcement Report27 statesnamed in where it went PublishedMar 27, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Montana, North Carolina, Nevada, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled Class IIFDA’s classMar 27, 2013in FDA’s Enforcement Report11 statesnamed in where it went PublishedMar 27, 2013ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Florida, Indiana, Massachusetts, Minnesota, New Hampshire, New Jersey, New York, Pennsylvania and Wisconsin
- Medical device recall INTIO Inc., ClearStart-SVM Segmentation and Volumetric Measurement System, Users Manual INTIO Inc. Class IIFDA’s classMar 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMar 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Florida, Minnesota, New York, Pennsylvania, Rhode Island and Wisconsin named
- Medical device recall Command Instrument Broach Handle Reports of handle fracture and subsequent disassociation of cam assembly subcomponents during use. Class IIFDA’s classMar 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 20, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Integra CUSA excel There is a potential for erosion of the CUSA EXcel tip used with the Nosecone. Class IIFDA’s classMar 20, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 20, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall 3.75mm x 12mm Fixed Cervical Screws Manufacturing residue may be present on the cervical screws. Class IIFDA’s classMar 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 20, 2013ClassClass IIStatusTerminatedWhereNationwide, and California and Texas named
- Medical device recall Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended to release A-1 pulley… Instratek, Inc.has received multiple complaints of the 1052 Trigger Finger Release Blades which could not be advanced into the cannula through which it is used… Class IIFDA’s classMar 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedMar 20, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Michigan, Nebraska, Nevada and Texas named
- Medical device recall Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Mislabeled: Genesis Straight Esthetic 5.0mm Contour ,3mm cuff labeled as Genesis Straight Esthetic 4.0 mm, 1 mm cuff abutment, Class IIFDA’s classMar 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedMar 20, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Indiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New York, Pennsylvania and Wisconsin named
- Medical device recall Genesis Straight Esthetic 5.0 mm 3 Mislabeled: Genesis Straight Esthetic 4.0mm Contour ,1mm cuff labeled as Genesis Straight Esthetic 5.0 mm, 3mm cuff abutment Class IIFDA’s classMar 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedMar 20, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Indiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New York, Pennsylvania and Wisconsin named
- Medical device recall REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical instrument The Straight Ringloc Button Latch Inserter Handle may have been manufactured at the higher end of the tolerance causing interference with the Ringloc cup. Class IIFDA’s classMar 20, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 20, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile Potential failure of the braking system that controls the O-arm Imaging System gantry movement in the vertical direction Class IIFDA’s classMar 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 20, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ANTI-BORRELIA (LYME) MICROPLATE EIA Kit Multiple incidents of low-reacting assay plates. Class IIFDA’s classMar 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedMar 20, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Massachusetts, Maryland, Maine, North Carolina, North Dakota, New Jersey, New York, Oregon, Virginia and Wisconsin named
- Medical device recall Isoline Implantable Defibrillation Lead Isoline defibrillation leads distributed may have internal insulation breach. Class IIFDA’s classMar 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 20, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AMO Sensar Intraocular Lenses (IOLs) Two production orders of these IOLs that contain mislabeled IOLs. Class IIFDA’s classMar 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 20, 2013ClassClass IIStatusTerminatedWhereNationwide, and Ohio named
- Medical device recall ACUSON S2000 Automated Breast Volume Scanner (ABVS) On some ACUSON S2000 ABVS systems, the inside of the transducer pod may contain sharp edges. Class IIFDA’s classMar 20, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 20, 2013ClassClass IIStatusTerminatedWhereOhio and West Virginia
- Medical device recall Elekta Synergy XVI The DICOM tags do not contain sufficient information for XVI to identify the different volumes that have the same name. Class IIFDA’s classMar 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedMar 20, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Cynch Lordotic T-PLlF Implant Implants were incorrectly laser marked as 23mm instead of 28mm. Class IIFDA’s classMar 20, 2013in FDA’s Enforcement ReportTexasthe one state its words name PublishedMar 20, 2013ClassClass IIStatusTerminatedWhereTexas
- Medical device recall Siemens Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge The analytical sensitivity claim of 6 ug/dL (1.1 umol/L) in the Instructions for Use (IFU) is no longer valid. Class IIIFDA’s classMar 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 20, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall GE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ Exposed high voltage wires inside the cabinet . Class IIFDA’s classMar 20, 2013in FDA’s Enforcement Report8 statesnamed in where it went PublishedMar 20, 2013ClassClass IIStatusTerminatedWhereFlorida, Illinois, Indiana, North Carolina, New Jersey, Oklahoma, Texas and Wisconsin
- Medical device recall Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T… An error on the SR Viewer Reporting Tool in which edits can be made on a report and can be saved into incorrect reports. Class IIFDA’s classMar 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 20, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with… A portion of a silicone wound drain was found to be cracked. Class IIFDA’s classMar 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMar 20, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Montana, Texas, Utah and Virginia 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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