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 CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure… Kit Label incorrect :Labeled with Lidocaine HCI drug cartridges Lidocaine HCl (2%) but contains vials Lidocaine HCl (1%) Class IIIFDA’s classOct 14, 2015in FDA’s Enforcement Report20 statesnamed in where it went PublishedOct 14, 2015ClassClass IIIStatusTerminatedWhereAlabama, Arizona, California, Georgia, Iowa, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Vermont
- Medical device recall Syngo RT Oncologist, an optional accessory to the linear accelerator system and permits localization,… This update is intended to provide a software update for the Syngo RT Oncologist, which is currently running SW version 4.2 or 4.3. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereMassachusetts, Missouri, Ohio, Pennsylvania, Utah and Wisconsin
- Medical device recall SOMATOM Force Software and firmware bugs Class IIFDA’s classOct 14, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MICroSTREP plus 1 Panel Beckman Coulter is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels because a manufacturing error may lead to antimicrobic degradation and the… Class IIFDA’s classOct 14, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MICroSTREP plus 2 Panel Beckman Coulter is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels because a manufacturing error may lead to antimicrobic degradation and the… Class IIFDA’s classOct 14, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Access Free T3 Reagent Kit, P/N A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent… Beckman Coulter, Inc. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120) The SP2 IM Rod 400mm Instrument (PN… DePuy Orthopaedics, Inc. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report41 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Monaco Radiation Treatment Planning System Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with forced densities. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereCalifornia, Indiana, Michigan, Missouri, Texas and Wisconsin
- Medical device recall MAJ-1606 Instrument Channel Adaptor small puncture marks in a sterile package for an accessory to an Olympus device Class IIFDA’s classOct 14, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Disposable Paper Filter for Sterilization Containers Paper, Medical Accessory, 100 DISP, Paper F,… Stryker has become aware that the inhomogeneity of the filter paper might potentially compromise the ability of the filter to maintain a sterile barrier during… 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 Histolock Resection Device, US Endoscopy The company has determined the sterility cannot be assured for the affected lot. Class IIFDA’s classOct 7, 2015in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 7, 2015ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Illinois, Indiana, Mississippi, Ohio, Oklahoma and Tennessee
- Medical device recall Carto 3 EP Navigation System Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial… Class IIFDA’s classOct 7, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial… Class IIFDA’s classOct 7, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips GoSafe Mobile Help Button Irregular battery disconnection resulted in issues with Mobile Health Button (MHB) Charging. Class IIFDA’s classOct 7, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedOct 7, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall PROFEMUR PLUS CoCr MODULAR NECK Unexpected rate of postoperative fractures resulting in the need for revision surgery. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 7, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2015ClassClass IStatusTerminatedWhereNationwide
- Medical device recall EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180 Insufficient information for specific cleaning accessories used for the cleaning and reprocessing of the GF-UCT180 ultrasound endoscope Class IIFDA’s classOct 7, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34” Single Hose Single Bladder Brown (PLC), 34” Sterilmed, Inc. Class IIFDA’s classOct 7, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 7, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Michigan, Ohio, Utah and Wisconsin named
- Medical device recall Zimmer Guide Wires for orthopedic procedures. Product labeling of these sterile guide wires (external carton label and patient record label) states a 10-year expiration date. Class IIFDA’s classOct 7, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 7, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall ASP-1020 LipoTower with Aspiration Pump There is potential risk of electrical shock if lead wires inside the device become detached and the ground connection fails. Class IIFDA’s classOct 7, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ASP-1021 LipoTower with Aspiration Pump and Tumescent Pump There is potential risk of electrical shock if lead wires inside the device become detached and the ground connection fails. Class IIFDA’s classOct 7, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall P/N: 9735023, DRIVER 9735023 SOLERA 5.5/6.0 MAS Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery. Class IIFDA’s classOct 7, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall P/N: 9734856, SCREWDRIVER, 9734856, SOLERA STD MAST Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery. Class IIFDA’s classOct 7, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes Manufacturer of 0.9% Sodium Chloride Flush Syringes recalled due to compromised sterility of the outer barrel, Arrow purchased recalled items that were… Class IIFDA’s classOct 7, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ferno iNX Wheeled Stretcher, Integrated Patient Transport & Loading System Product Usage: Stretcher for… Hole elongation in the telescoping load frame channel. Class IIFDA’s classOct 7, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedOct 7, 2015ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Iowa, Illinois, Indiana, Kentucky, Maryland, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Texas, Virginia, Washington and Wyoming named
- Medical device recall ThruPort Knot Pusher The configuration of the slot at the tip of the knot pusher may inhibit intended ease of use. Class IIFDA’s classSep 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Terumo Custom Cardiovascular Procedure Kit Tubing Pack P/N: 66041-1 Terumo Cardiovascular Procedure Kits are Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators Class IIFDA’s classSep 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedSep 30, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida and Wisconsin named
- Medical device recall Terumo Custom Cardiovascular Procedure Kit X-Coated Adult Pak P/N: 73124 Terumo Cardiovascular Procedure Kits… Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators Class IIFDA’s classSep 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedSep 30, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida and Wisconsin named
- Medical device recall Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack with FX25RE P/N: 7928-03 Terumo… Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators Class IIFDA’s classSep 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedSep 30, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida and Wisconsin named
- Medical device recall Terumo Custom Cardiovascular Procedure Kit X-Coated Pediatric Pack P/N: 74039-02 Terumo Cardiovascular… Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators Class IIFDA’s classSep 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedSep 30, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida and Wisconsin named
- Medical device recall Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack P/N: 74077-01 Terumo Cardiovascular… Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators Class IIFDA’s classSep 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedSep 30, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida and Wisconsin named
- Medical device recall Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75185 Terumo Cardiovascular… Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators Class IIFDA’s classSep 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedSep 30, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida and Wisconsin named
- Medical device recall Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75529 Terumo Cardiovascular… Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators Class IIFDA’s classSep 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedSep 30, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida and Wisconsin named
- Medical device recall Microtek Medical, Inc The sterile packaging may contain small (less than 250 microns wide) channels in the seal of the pouch. Class IIFDA’s classSep 30, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 30, 2015ClassClass IIStatusTerminatedWhereDistrict of Columbia and Puerto Rico
- Medical device recall Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm DLS pin breakage during planned implant removal, after uneventful and successful healing of the fracture. Class IIFDA’s classSep 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Disposable Reflective Marker Spheres The Disposable Reflective Marker Spheres used in conjunction with a… Disposable Reflective Marker Spheres (DRMS) for Brainlab Image Guided Surgery (IGS) Systems: DRMS spheres may separate at the mid-point where the two halves of… Class IIFDA’s classSep 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedSep 30, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Michigan, New York, Ohio, Pennsylvania, Tennessee and Texas named
- Medical device recall 3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System The 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw, Lot # 150192-J package may contain a different screw. Class IIFDA’s classSep 30, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 30, 2015ClassClass IIStatusTerminatedWhereIowa and Tennessee
- Medical device recall Contra-Angles CA1:1L EVO 15 Possible loosening of the dental tool, which may lead to potential swallowing of the tool. Class IIFDA’s classSep 30, 2015in FDA’s Enforcement ReportFloridathe one state its words name PublishedSep 30, 2015ClassClass IIStatusTerminatedWhereFlorida
- Medical device recall Regard Custom Surgical Pack Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance. Class IIFDA’s classSep 30, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 30, 2015ClassClass IIStatusTerminatedWhereLouisiana and South Carolina
- Medical device recall Regard Custom Surgical Pack Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance. Class IIFDA’s classSep 30, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 30, 2015ClassClass IIStatusTerminatedWhereLouisiana and South Carolina
- Medical device recall PenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut or trim sutures and catheters… Cracks were discovered in the PET tray of a small population of sterile product. Class IIFDA’s classSep 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Lightspeed 16 CT Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner. Class IIFDA’s classSep 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PET Discovery LS Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner. Class IIFDA’s classSep 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PET Discovery ST 16 Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner. Class IIFDA’s classSep 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The Leica ASP6025 Tissue Processor The ASP6025 Tissue Processor instrument is incorrectly getting into a state of bottle empty during retort filling, after passing the fill lever sensor 2 and… Class IIFDA’s classSep 30, 2015in FDA’s Enforcement Report34 statesnamed in where it went PublishedSep 30, 2015ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Fujinon/Fujifilm Processor EPX 2500 Operation Manual The EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope is meant to be used with the EPX-2500 Processor. Class IIFDA’s classSep 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fujifilm Processor EPX 2500 High Definition Endoscopy The EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope is meant to be used with the EPX-2500 Processor. Class IIFDA’s classSep 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V New and validated reprocessing procedures have been issued for the Olympus TJF-Q180V duodenoscope (“TJF-Q180V”), consisting of revised manual cleaning and high… Class IIFDA’s classSep 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Marketing brochures for the PowerPICC and PowerPICC SOLO catheters Bard Access Systems is recalling marketing brochures for the PowerPICC¿ and PowerPICC¿ SOLO¿ catheters due to incorrect indication for use contained in the… Class IIFDA’s classSep 30, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 30, 2015ClassClass IIStatusTerminatedWhereNo state 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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