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 Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B Antibiotic concentration may be insufficient which may result in incorrect test results. Class IIFDA’s classDec 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedDec 23, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Massachusetts, Missouri, North Carolina, New York, Puerto Rico, Texas and Virginia named
- Medical device recall Unolok Blunt Fill Needle 18G x 1.5” Red, Sterile, Single use, Non-injectable needle, Single use,… Particulates: Complaints of rubber coring from the closure of injection vials. Class IIFDA’s classDec 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedDec 23, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, New Jersey, Nevada, New York, Oklahoma, Pennsylvania, Texas and Utah named
- Medical device recall Intravascular (IV) Administration Sets Edward Lifesciences is recalling Intravascular (IV) Administration Sets due to the requirement of an additional FDA submission to support commercialization… Class IIFDA’s classDec 23, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 23, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall MOSAIQ Oncology Information System First Databank (FDB) is a third party product incorporated into MOSAIQ. Class IIFDA’s classDec 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedDec 23, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Valeant Pharmaceuticals North America SPAG-2 6000 Lot J3522070 was released to commerce without being tested for particle size per quality control procedure SPAG-2515. Class IIFDA’s classDec 16, 2015in FDA’s Enforcement Report13 statesnamed in where it went PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Illinois, Missouri, North Carolina, New York, Ohio, Pennsylvania, South Carolina, Texas and Utah
- Medical device recall Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT - 62 MM, STERILE R The devices were packaged and laser marked anatomically incorrect. Class IIFDA’s classDec 16, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, RIGHT - 62 MM, STERILE R The devices were packaged and laser marked anatomically incorrect. Class IIFDA’s classDec 16, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue: 866023… Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification Class IIFDA’s classDec 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/Right Sterile (The TFN-ADVANCED… TFNA nails may have the locking mechanism too close to the top of the nail. Class IIFDA’s classDec 16, 2015in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereCalifornia, Florida, Michigan and Wisconsin
- Medical device recall AMS 4674 Custom Pack AMS 4674 Custom Pack is recalled because this kit containing U-SDN 2 Part Ultra Modified Seldinger Needle which is recalled by supplier. Class IIFDA’s classDec 16, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereAlabama and Virginia
- Medical device recall AMS 4675 Angio Pack AMS 4675 Angio Pack is recalled because this kit containing U-SDN 2 Part Ultra Modified Seldinger Needle which is recalled by supplier. Class IIFDA’s classDec 16, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereAlabama and Virginia
- Medical device recall LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. Class IIFDA’s classDec 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. Class IIFDA’s classDec 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. Class IIFDA’s classDec 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. Class IIFDA’s classDec 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. Class IIFDA’s classDec 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 40 cm Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. Class IIFDA’s classDec 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. Class IIFDA’s classDec 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. Class IIFDA’s classDec 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. Class IIFDA’s classDec 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. Class IIFDA’s classDec 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. Class IIFDA’s classDec 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. Class IIFDA’s classDec 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. Class IIFDA’s classDec 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging. Class IIFDA’s classDec 16, 2015in FDA’s Enforcement Report10 statesnamed in where it went PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Georgia, Maryland, Michigan, North Carolina, New York, Ohio and Washington
- Medical device recall The “Pacifier Activated Lullaby” (PAL) System composed of three major components: 1) the PAL Player Module… PAL unit has undergone significant technological changes since the previous 510(k) and labeling is not consistent with the cleared indications of the 510(k). Class IIFDA’s classDec 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 16, 2015ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DGDE, DirectGuide Drill Extender Implant Direct Sybron Manufacturing, LLC is recalling 26 lots of DGDE DirectGuide Drill Extender because of a possible dropping of the drill. Class IIFDA’s classDec 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Massachusetts, Michigan, Missouri, Nevada, Ohio, Oregon, Pennsylvania, South Carolina, Texas and Virginia named
- Medical device recall IBS - Osteosynthesis screws for bone fixation One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw head. Class IIFDA’s classDec 16, 2015in FDA’s Enforcement ReportTennesseethe one state its words name PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall Thin-Flex Venous Cannula Edwards Lifesciences initiated a field action for the Thin-Flex Venous Cannula (Model TF292902A) because the connector size is incorrectly described in the… Class IIFDA’s classDec 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The eCareManager system A software defect may cause incorrect medication order change. Class IIFDA’s classDec 16, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Brilliance CT (computed tomography) scanners, Big Bore configuration Brilliance Big Bore- An anomaly was identified with software version 2.0 tumor localization application when printing work sheets. Class IIFDA’s classDec 16, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereCalifornia and Nevada
- Medical device recall GE Healthcare, Revolution CT Scanners GE Healthcare has recently become aware of a potential issue with routine head scans on your Revolution CT scanner. Class IIFDA’s classDec 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Connecticut, Florida, Georgia, Hawaii, Illinois, North Carolina, New York, Ohio, Oregon, Pennsylvania, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube. Boston Scientific Corp. Class IIFDA’s classDec 16, 2015in FDA’s Enforcement Report9 statesnamed in where it went PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Indiana, Nevada, New York, Pennsylvania, Tennessee, Washington and Wisconsin
- Medical device recall Olympus ENDOEYE HD II Video Telescopes A damaged temperature sensor at the ENDOEYE tip caused the distal end to become abnormally hot. Class IIFDA’s classDec 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Florida, Georgia, Iowa, Illinois, Indiana, Michigan, Mississippi, North Dakota, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Texas and Washington named
- Medical device recall Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO Sterilmed, Inc. Class IIFDA’s classDec 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Brilliance 64 Computed Tomography X-Ray System Multiple software defects which could impact the performance or reliability of the system. Class IIFDA’s classDec 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Persona EM Proximal Tube, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item… Complaints that the ratchet teeth of the tube are not latching onto the rod. Class IIFDA’s classDec 16, 2015in FDA’s Enforcement Report19 statesnamed in where it went PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereArizona, California, Idaho, Illinois, Indiana, Kansas, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Washington
- Medical device recall Persona EM Distal Rod, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item… Complaints that the ratchet teeth of the tube are not latching onto the rod. Class IIFDA’s classDec 16, 2015in FDA’s Enforcement Report19 statesnamed in where it went PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereArizona, California, Idaho, Illinois, Indiana, Kansas, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Washington
- Medical device recall Medtronic InSync III Medtronic has confirmed an issue with InSync III CRT-pacemaker devices related to long-term battery performance. Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall Copper NiTi Preformed Archwires Ormco Corporation is recalling Copper NiTi Preformed Archwires because the product transformation temperature as listed on the labeling is incorrect. Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Two-stage and three-stage I.V It was identified by a customer complaint that some I.V. Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Guam named
- Medical device recall HYDRO-TEMP(R) Neonatal Temperature Skin Sensor DeRoyal manufactured four lots of HNICU-32, Hydro-Temp(R) Neonatal Temperature Skin Sensor incorrectly. Class IIFDA’s classDec 9, 2015in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereAlabama, California, Florida and Virginia
- Medical device recall Philips Healthcare Allura Xper Series: Allura Xper FD10 Allura Xper FD10/10 Allura Xper FD20 Allura Xper FD21… Monitor Ceiling Suspension system may fall Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips Healthcare Allure BiPlane Series Monitor Ceiling Suspension system may fall Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips Healthcare INTEGRIS cardio system Monitor Ceiling Suspension system may fall Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips Healthcare INTEGRIS vascular System Monitor Ceiling Suspension system may fall Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips Healthcare INTEGRIS H5000F/Allura 9F Monitor Ceiling Suspension system may fall Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips Healthcare Xper cardio systems Monitor Ceiling Suspension system may fall Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 9, 2015ClassClass 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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