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 Zimmer Natural Nail CM Long In about 5% of tested samples, the outer tray was found to be compromised. Class IIFDA’s classOct 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 21, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall -Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Flex Embolization… The firm is recalling Pipeline and Pipeline Flex Embolization Devices from U.S. Class IIFDA’s classOct 21, 2015in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 21, 2015ClassClass IIStatusTerminatedWhereIllinois, Kentucky, Maryland, Missouri, Oregon, Tennessee, Utah, Virginia and Wisconsin
- Medical device recall Monode, Shortwave Accessory Overheating and burning of the wire insulation inside the applicator. Class IIFDA’s classOct 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedOct 21, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arkansas, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773 Alere San Diego is recalling the Alere Cholestech LDX Multianalyte Control because the assigned control ranges for the Total Cholesterol (TC) and Triglyceride… Class IIIFDA’s classOct 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 21, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall The Ebb Complete Tamponade System Clinical Innovations, LLC is voluntarily recalling the Ebb Complete Tamponade System (CTS-1000) Lot Number 1214-F-403.) to address the potential for a balloon… Class IIFDA’s classOct 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedOct 21, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Florida, Indiana, Louisiana, Maryland, Mississippi, North Carolina and Tennessee named
- Medical device recall Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile and Synthes 2.7MM/3.5MM VA-LCP… The 2.7MM/3.5MM VA-LCP Humerus Plates were found to be labeled incorrectly. Class IIFDA’s classOct 21, 2015in FDA’s Enforcement Report19 statesnamed in where it went PublishedOct 21, 2015ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Michigan, Minnesota, North Carolina, North Dakota, New Jersey, Ohio, Pennsylvania, Tennessee, Virginia and West Virginia
- Medical device recall Inserter for Titanium Elastic Nails (TEN), orthopedic device potential for mechanical failures such as breakage. Class IIFDA’s classOct 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 21, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Synthes Screw Inserter Certain lots of the Screw Inserter may be etched with incorrect graphics. Class IIFDA’s classOct 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 21, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 4FR Single Lumen Pressure Injectable PICC Labeling inaccuracy in the Instructions for Use (IFU) and Patient Card. Class IIFDA’s classOct 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 21, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Celesteion PCA-9000A/2 PET/CT System It was found that if specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved due to a software problem. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement ReportNevadathe one state its words name PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereNevada
- Medical device recall SOMATOM Definition Edge software bug issues for SW-Version VA48A_SP0. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SOMATOM Definition Flash software bug issues for SW-Version VA48A_SP0. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SOMATOM Definition AS, intended to produce cross-sectional images of the body by computer reconstruction of… software bug issues for SW-Version VA48A_SP0. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic Medical Device Identification Card for SureScan pacemaker patients Some Medical Device Identification Cards provided to SureScan pacemaker patients indicate they have a complete Magnetic Resonance (MR) Conditional system, when… Class IIFDA’s classOct 14, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images… Images may be missing when a system parameter MapRoute is set to a value greater than 1. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticular Aiming Arm for… Affected lots of Periarticular Aiming Arms and Insertion Handles (Part Numbers 03.120.001, 03.120.002, 03.120.004 and 03.120.005) for the 4.5 mm LCP Proximal… Class IIFDA’s classOct 14, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter,… Integra identified that the UCHRAP component (Arc Adapter Plate) would not assemble properly to the UCHRAR component (ARC Adapter Ring) of the Compact Head… Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereNew Jersey, Texas and Wyoming
- Medical device recall Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business… Ortho Solutions Inc is initiating a recall on behalf of UltOS 3.5mm locking screw. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Georgia, Illinois, Louisiana, North Carolina, New York, Texas and Washington
- Medical device recall Zimmer Universal Locking System, Titanium 3.5mm It was found through review of open Complaints and stock investigations that a single lot of Zimmer Universal Locking System 3.5 mm Stainless Steel Base and… Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereAlabama, California, Kansas, North Carolina, Texas and Utah
- Medical device recall regard Item Number: 800091, Sterile, LD0692 - C Section - surgical kit containing cover light handle soft,… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800401, Sterile, GS0470 - Lap Pk - surgical kit containing cover light handle soft, RX.… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800407, Sterile, OR0476 - Ortho Pk - surgical kit containing cover light handle soft, RX.… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800408, Sterile, LD0477 - C-Section Pk - surgical kit containing cover light handle soft,… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800409, Sterile, GS0478 - LAP Chole Pk - surgical kit containing cover light handle soft,… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800410, Sterile, CV0479 - Open Heart Pk - surgical kit containing cover light handle… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800411, Sterile, NU0480 - Neuro Pk - surgical kit containing cover light handle soft, RX.… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800413, Sterile, CV0482 - Vascular Pk - surgical kit containing cover light handle soft,… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800414, Sterile, OR0483 - Total Joint Pk - surgical kit containing cover light handle… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800415, Sterile, OR0484 - Shoulder System Pk - surgical kit containing cover light handle… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800416, Sterile, GY0485 - Robotic Hysterectomy Pkg - surgical kit containing cover light… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800417, Sterile, GY0486 - Laparoscopy Pk - surgical kit containing cover light handle… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800418, Sterile, GY0487 - Major Vaginal Pk - surgical kit containing cover light handle… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800419, Sterile, GY0488 - D&C Pk - surgical kit containing cover light handle soft, RX.… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800422, Sterile, OR0491 - Arthroscopy Pk - surgical kit containing cover light handle… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800425, Sterile, CV0494 - AV Access Pk -Spohn surgical kit containing cover light handle… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800508, Sterile, LD0586 - C Section - surgical kit containing cover light handle soft,… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800514, Sterile, LD0592 - C Section Pack - surgical kit containing cover light handle… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800524, Sterile, LD0608 - C Section - surgical kit containing cover light handle soft,… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800525, Sterile, OR0609 - Extremity Pack - surgical kit containing cover light handle… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800526, Sterile, ET0610 - Head and Neck - surgical kit containing cover light handle… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800527, Sterile, OR0611 - Hip Shoulder Pk - surgical kit containing cover light handle… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800528, Sterile, GS0612 - Lap Chole Pk - surgical kit containing cover light handle soft,… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800531, Sterile, NU0615 - Neuro Pk - surgical kit containing cover light handle soft, RX.… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800532, Sterile, GY0616 - Vaginal Hysterectomy - surgical kit containing cover light… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800533, Sterile, GS0606 - Abdominal Pk - surgical kit containing cover light handle soft,… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800535, Sterile, LD0620 - C Section - surgical kit containing cover light handle soft,… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800546, Sterile, GS0635 - Abdominal - surgical kit containing cover light handle soft,… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800548, Sterile, OR0637 - Extremity - surgical kit containing cover light handle soft,… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
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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