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 KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece (Product Code 22705) The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or… 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 KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 2271418) A… The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or… 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 KimVent* Multi-Access Port Closed Suction System for Adults, Endotracheal, DSY, 14 F (Product Code 24014-5) A… The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or… 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 KimVent* Multi-Access Port Replacement Catheter for Adults,Tracheostomy, 14 F (Product Code 2401453-5) A… The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or… 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 KimVent* Multi-Access Port Closed Suction System for Adults,Tracheostomy, DSY, MDI, 14 F (Product Code… The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or… 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 KimVent* Multi-Access Port Replacement Catheter for Adults, Endotracheal,16 F (Product Code 240165-5) A… The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or… 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 KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Y-Adapter (Product Code 195) The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or… 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 KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Manifold (Product Code 201) A tracheobronchial… The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or… 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 KimVent* Closed Suction System for Neonates/Pediatrics, 6 F, Elbow (Product Code 206) The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or… 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 KimVent* Wet Pak* Closed Suction System for Pediatrics, 10 F, Y Adapter (Product Code 8281) A… The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or… 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 Neptune 2 Waste Management System Docking Station The Fluid Coupling Sleeve, a component within the Neptune Waste Management System Docker, may be out of specification. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Monoject 0.9% Saline Flush Prefill Double Pouch Sterility may be compromised Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Mahurkar Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety Components, 13.5 FR x… Sterility may be compromised Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Mahurkar Acute Dual Lumen Catheter Tray, High Flow¿ Pre-Curved with IC* Safety Components, 13.5 FR x 13.5 cm Sterility may be compromised Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety Components, 13.5… Sterility may be compromised Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Pre-Curved with IC* Safety Components, 13.5 Fr x 20… Sterility may be compromised Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Mahurkar” Elite Acute Dual Lumen Catheter Tray, Straight Extensions with IC* Safety Components, 12 Fr x 20 cm Sterility may be compromised Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12 Fr x 16 cm Sterility may be compromised Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12 Fr x 20 cm Sterility may be compromised Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12.5 Fr x 13 cm Sterility may be compromised Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12.5 Fr x 20 cm Sterility may be compromised Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16cm, Curved Extensions, PASS Tray Sterility may be compromised Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MAHURKAR”* 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Curved Extensions, PASS Tray Sterility may be compromised Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Straight Extensions, PASS Tray Sterility may be compromised Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Panoramic X-ray Jackscrew nut part failure potentially leading to device malfunction and patient/operator injury. 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 SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement Report16 statesnamed in where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Florida, Kansas, Louisiana, Michigan, Minnesota, Missouri, Montana, North Carolina, Nevada, New York, Ohio, Texas and Washington
- Medical device recall SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement Report16 statesnamed in where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Florida, Kansas, Louisiana, Michigan, Minnesota, Missouri, Montana, North Carolina, Nevada, New York, Ohio, Texas and Washington
- Medical device recall CrossCHECK Locking Screw in the following sizes: 3.0 x 8 mm These screws have a potential of passing through the plate in the case when torque is applied in excessive amounts, which may result in intraoperative… Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CrossCHECK Non-Locking Screw in the following sizes: 3.0 x 8 mm These screws have a potential of passing through the plate in the case when torque is applied in excessive amounts, which may result in intraoperative… Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall cobas Liat Analyzer, for in vitro diagnostic use. Due to a supplier issue, the incorrect green and amber LED components were used in the manufacture of the LED printed circuit board assemblies (PCBA) in… Class IIFDA’s classSep 9, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNorth Carolina and Texas
- Medical device recall VITROS 5,1 FS Chemistry System Software anomaly may occur during the installation of an Assay Data Diskette (ADD) using Software Versions 2.2.1 through 2.8. 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 MediTrace Cadence Adult Multi-Function Defibrillation Electrodes Multi-Function Defibrillation Electrodes, Pre connect- potential for damage to the wire insulation may result in a potentially increased risk for reduced or no… Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MediTrace Cadence Adult Zoll, Preconnect Defibrillation Electrode, Nonsterile Multi-Function Defibrillation Electrodes, Pre connect- potential for damage to the wire insulation may result in a potentially increased risk for reduced or no… Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak¿ Preconnect System Multi-Function Defibrillation Electrodes, Pre connect- potential for damage to the wire insulation may result in a potentially increased risk for reduced or no… Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ANGIODRAPE 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 SUTURE REMOVAL KIT CUSTOMED 100/CS Used by medical staff to perform patient care procedures such as wound… 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 O.B. PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound… 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 IRRIGATION TRAY W/BULB SYRINGE CUSTOMED 50/CS Used by medical staff to perform 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 LAPAROSCOPY PK 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 UNIVERSAL DRAINAGE TRAY CUSTOMED 20/CS Used by medical staff to perform surgical procedures and patient care… 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 MAJOR LAPAROTOMY PK 4/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 MINOR PROCEDURE PACK 40/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 WOUND CLOSURE TRAY I CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care… 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 WOUND CLOSURE TRAY II CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care… 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 CYSTO TUR PACK CUSTOMED 10/CS REV 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 OB PACK CS/4 Used by medical staff to perform surgical procedures and patient care procedures such as wound… 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 LAPAROSC CHOLE 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
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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