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 6, 2026.
2,495of 2,495 medical device recallsshown with your filters
The list
- Medical device recall LAPAROTOMY PACK CS/6 Used by medical staff to perform surgical procedures and patient care procedures such as… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall CESAREAN PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall UROLOGY PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall ARTHROSCOPY PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall CURATION KIT 10/CS Used by medical staff to perform surgical procedures and patient care procedures such as… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall PLASTIC SURGERY PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall C-SECTION SURGICAL PACK 2/CS Used by medical staff to perform surgical procedures and patient care procedures… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall CATARACT PACK 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall ARTHROSCOPY PK L/F 5/CS Used by medical staff to perform surgical procedures and patient care procedures such… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall LAPAROTOMY PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall PERI GYN PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall C-SECTION PK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Volcano Pioneer Plus Re-Entry Catheter Due to a manufacturing defect, there is the possibility that a small wire could extend through the catheter shaft of the Pioneer Plus intravascular Ultrasound… Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Syngo.plaza; picture archiving and communications system Product Usage: Syngo.plaza is a Picture Archiving… Potential issue leading to data loss and patient data mix-up Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Kansas, Massachusetts, Maryland, Minnesota, Missouri, New York, Oregon, Pennsylvania, Washington and Wisconsin named
- Medical device recall Transonic Flow Probe, 2 mm Software defect; programming errors in the blood flow probes EPROM. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Transonic Flow Probe, 3 mm Software defect; programming errors in the blood flow probes EPROM. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Transonic Flow Probe, 6 mm Software defect; programming errors in the blood flow probes EPROM. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Transonic Flow Probe, 8 mm Software defect; programming errors in the blood flow probes EPROM. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Transonic Flow Probe, 2 mm Software defect; programming errors in the blood flow probes EPROM. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Transonic Flow Probe, 3 mm Software defect; programming errors in the blood flow probes EPROM. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Transonic Flow Probe, 2 mm Software defect; programming errors in the blood flow probes EPROM. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Transonic Flow Probe, 3 mm Software defect; programming errors in the blood flow probes EPROM. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Transonic Flow Probe, 4 mm Software defect; programming errors in the blood flow probes EPROM. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Transonic Flow Probe, 6 mm Software defect; programming errors in the blood flow probes EPROM. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test The devices that included the OVAR research test were not cleared for marketing and mTBI research package was sold with the incorrect investigational label. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip Potential breach of the sterile barrier packaging. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement Report14 statesnamed in where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Massachusetts, Minnesota, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Texas and Washington
- Medical device recall Access Thyroglobulin Assay Beckman Coulter, Inc. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall da Vinci Xi Surgical System P4 software;with Xi Stapler Complaints regarding the Exposed Knife Blade recoverable fault for the Xi Stapler with Xi System P4 version software. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01 Ethicon has found that disinfecting methods not specified in the Instructions For Use (IFU) have led to the degradation of the plastic material of the SEDASYS… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedSep 2, 2015ClassClass IStatusTerminatedWhereNationwide, and Ohio, Rhode Island, Texas and Washington named
- Medical device recall Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1 The system is designed to emit a beep upon termination of an exposure. Class IIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Minnesota, Ohio, Washington and Wyoming named
- Medical device recall Otto Bock Healthcare Products GmbH Genium X3 Otto Bock Healthcare Products GmbH is recalling the new Genium X3 knee joint prosthesis due to issues with the resistance-control of the hydraulics, which may… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement ReportOhiothe one state its words name PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereOhio
- Medical device recall PTW UNIDOS webline: 1) In some cases, especially with high dose-per-pulse-rates typical for particle (specifically proton) therapy, measuring errors can result. Class IIFDA’s classSep 2, 2015in FDA’s Enforcement Report10 statesnamed in where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereCalifornia, Massachusetts, Michigan, North Carolina, New Jersey, New York, Pennsylvania, Tennessee, Texas and Wisconsin
- Medical device recall ExacTrac 6.0.x Patient Positioning System, Radiation therapy ExacTrac 6.0 Patient Positioning System: Display of potentially incorrect Digitally Reconstructed Radiograph (DRR) for x-ray correction and verification. Class IIFDA’s classSep 2, 2015in FDA’s Enforcement Report32 statesnamed in where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, North Dakota, Nebraska, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall iChemVELOCITY Automated Urine Chemistry Iris International is recalling the iChemVELOCITY systems because they do not maintain the on-board strip stability claim of 5 days at 18-28 degrees celsius at… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Guardian Real-Time Monitor Medtronic MiniMed is recalling the Guardian Real-Time Continuous Glucose Monitoring System because it has a language translation error that impacts the Finnish… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Covidien Argyle Infant Heel Warmers (no tab) Infant Heel warmers may break during activation resulting in spillage of the contents on patients or healthcare worker causing potential skin/eye irritations Class IIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Argyle Infant Heel Warmers (with tab) Infant Heel warmers may break during activation resulting in spillage of the contents on patients or healthcare worker causing potential skin/eye irritations Class IIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells The device may have improper screw hole placement due to inaccurate location of the index line. Class IIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Illinois, Massachusetts, New York, Oklahoma, Tennessee, Utah, Virginia and Wyoming named
- Medical device recall cobas b 123 Fluid Pack COOX Low PO2 results. Class IIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Louisiana, Nebraska, Puerto Rico, South Carolina, Texas, Virginia and West Virginia named
- Medical device recall cobas b 123 Fluid Pack COOX Low PO2 results. Class IIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Louisiana, Nebraska, Puerto Rico, South Carolina, Texas, Virginia and West Virginia named
- Medical device recall LX3 Floor Stand for Endure Luxite Envision Optical System Alcon is initiating a voluntary recall of all LX3 Microscope Floor Stands after receiving reports concerning loss of functionality due to issues with the… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray… Software defect that impacts image alignment when using the automatic stitching option for long length images. Class IIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dimension Vista B¿2-Microglobulin Flex Reagent Cartridge (B2MIC) customers are receiving a high number of Abnormal Assay Errors or are not able to calibrate B2MIC when using Flex reagent cartridge B2MIC various lots. Class IIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, New York, Tennessee and Wisconsin named
- Medical device recall Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large) Labeling changes were made related to MR conditions that align with standard definitions for MR Safe, MR Conditional, and MR Unsafe. Class IIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 3.0/4.0 Cannulated Drill Bit The cannulation of the 3.0/4.0 Cannulated Drill Bit inner diamter is too small to allow for the guide wire to pass completely through. Class IIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Iowa, Indiana, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Puerto Rico, South Carolina, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall BD CD56 PE Cy 7: NCAM16.2 ASR Analyte Specific Reagent Three lots of CD56 PE Cy 7, Catalog number 335809, contain a low amount of HLA-DR PE antibody which could result in an unexpected staining pattern. Class IIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Offset Femoral Alignment Guide, 2mm x 6¿ The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Class IIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Massachusetts, Ohio and Oklahoma named
- Medical device recall Offset Femoral Alignment Guide 4mm x 6¿ The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Class IIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Massachusetts, Ohio and Oklahoma 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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