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 Boston Scientific, Chariot ST-CCV Guiding Sheath, Sterilized using ethylene oxide: Product Description… Boston Scientific is voluntarily recalling its Chariot” Guiding Sheath. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedDec 30, 2015ClassClass IStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Flexible Screw Driver SJ706R The flexible shaft of the instruments may break during orthopedic spinal surgery. Class IIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Flexible Bone Awl The flexible shaft of the instruments may break during orthopedic spinal surgery. Class IIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Flexible Drill The flexible shaft of the instruments may break during orthopedic spinal surgery. Class IIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator The firm became aware of cases in which the battery run times of the optional PS 500 power supply unit with the Infinity Workstation Critical Care (Evita… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedDec 30, 2015ClassClass IStatusTerminatedWhereNationwide, and Alaska, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Etest¿ Piperacillin/tazobactam Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedDec 30, 2015ClassClass IStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Hawaii, Iowa, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Etest¿ PIP/TAZO/CON-4 PTC 256 -pack of 30 tests US Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedDec 30, 2015ClassClass IStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Hawaii, Iowa, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests WW Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedDec 30, 2015ClassClass IStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Hawaii, Iowa, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests US Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedDec 30, 2015ClassClass IStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Hawaii, Iowa, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Alaris Pump SmartSite Infusion Set CareFusion is recalling the Alaris Pump Module SmartSite Infusion Set because the disconnection and leakage may occur during infusion. Class IIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Tray Set containing multiple instruments and may contain the flexible bone awl, flexible drill and/or… The flexible shaft of the instruments may break during orthopedic spinal surgery. Class IIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Label reading in part as: “NexGen System, Complete Knee Solution Complaints were received from Thailand reporting that there was no white paper (Tyvek) seal on the inner package of P/N:00-5980-037-01 unit from lot #62460264 Class IIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall A.L.P.S. 4.0mm Cancellous Locking Screws intended for use in stabilization and fixation of fractures,… These screws have a single lead (instead of a triple lead) thread. Class IIFDA’s classDec 30, 2015in FDA’s Enforcement Report51 statesnamed in where it went PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, 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, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and allows a… The firm is recalling the Shimadzu Mobile X-ray system because an image may not transfer to image server properly. Class IIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Double Trigger Handpiece The firm identified a malfunction which made it possible for a handpiece to start by itself when the power source is connected. Class IIFDA’s classDec 30, 2015in FDA’s Enforcement Report32 statesnamed in where it went PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Kansas, Kentucky, Louisiana, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Single Trigger Handpiece The firm identified a malfunction which made it possible for a handpiece to start by itself when the power source is connected. Class IIFDA’s classDec 30, 2015in FDA’s Enforcement Report32 statesnamed in where it went PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Kansas, Kentucky, Louisiana, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Aegis Torque Handle Manufacturing error within the Torque Handle may prohibit some handles from being able to fully assemble with the tightener shaft. Class IIFDA’s classDec 30, 2015in FDA’s Enforcement Report9 statesnamed in where it went PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Idaho, Maryland, Michigan, North Carolina, New York and Texas
- Medical device recall Alaris EtCO2 Module CareFusion is recalling the Alaris EtCO2 module model 8300 because it may have been tested during service using a higher than specified concentration of CO2. Class IIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes Some tubes were manufactured with the stopper not fully inserted into the tube. Class IIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DA-2006P - Defibrillator / Pacer Analyzer Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms. Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide, and Florida and South Carolina named
- Medical device recall Reagent Management System (RMS) Dimension EXL with LM Product Usage: The Reagent Management System (RMS) is a… Siemens has identified RMS refrigeration compressors that are missing the safety cover on the electrical termination block. Class IIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Wisconsin and Wyoming named
- Medical device recall Reagent Management System (RMS) Dimension EXL with LM STM Product Usage: The Reagent Management System (RMS)… Siemens has identified RMS refrigeration compressors that are missing the safety cover on the electrical termination block. Class IIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Wisconsin and Wyoming named
- Medical device recall Reagent Management System (RMS) Dimension RxL Max w/o HM Product Usage: The Reagent Management System (RMS)… Siemens has identified RMS refrigeration compressors that are missing the safety cover on the electrical termination block. Class IIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Wisconsin and Wyoming named
- Medical device recall Reagent Management System (RMS) Dimension RxL Max HM STM Product Usage: The Reagent Management System (RMS)… Siemens has identified RMS refrigeration compressors that are missing the safety cover on the electrical termination block. Class IIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Wisconsin and Wyoming named
- Medical device recall IntellaTip MiFi XP Asymmetric (N4) Curve, 7/110/2.5/8-8 OUS During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate for distal tip bends/kinks was above the anticipated rate in… Class IIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 OUS During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate for distal tip bends/kinks was above the anticipated rate in… Class IIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-8 Material Number: M004PM4500N40 During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate for distal tip bends/kinks was above the anticipated rate in… Class IIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate for distal tip bends/kinks was above the anticipated rate in… Class IIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall Zimmer Oscillating Flat - TS ST Hub Two lots of oscillating saw blades incorrectly identify the blade cutting width as 25mm instead of the correct specification of 19mm. Class IIFDA’s classDec 30, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereCalifornia, Connecticut and Massachusetts
- Medical device recall MAGNETOM systems, magnetic resonance diagnostic devices (MRDD). Possible installation error of the quench lines of superconducting magnets, used to vent helium gas in the rare event of a quench. Class IIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Puerto Rico and US Virgin Islands named
- Medical device recall Factor VIII Chromogenic Assay, REF/Catalog No Factor VIII Chromogenic Assay Lot 44637 is showing an increased occurrence of irregular curves when used for measurement on Sysmex CA-1500, CA-7000, CS-2000i,… Class IIFDA’s classDec 30, 2015in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereMassachusetts
- Medical device recall Hook Blade, Angled The sterile blade will not fit into the handle provided with the ETTD system. Class IIFDA’s classDec 30, 2015in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereColorado, New York, Texas and Utah
- Medical device recall FB Broth, 10ml (Fastidious Bacteria Broth) The firm is recalling FB Broth Cat. Class IIFDA’s classDec 30, 2015in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereCalifornia, Maryland, Utah and Wisconsin
- Medical device recall Black Mamba Suture Passer There may be a separation and an insufficient weld between the spring and washer. Class IIFDA’s classDec 30, 2015in FDA’s Enforcement Report20 statesnamed in where it went PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Florida, Georgia, Hawaii, Indiana, Kansas, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Texas, Utah, Virginia and Wisconsin
- Medical device recall Green Mamba Suture Passer There may be a separation and an insufficient weld between the spring and washer. Class IIFDA’s classDec 30, 2015in FDA’s Enforcement Report20 statesnamed in where it went PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Florida, Georgia, Hawaii, Indiana, Kansas, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Texas, Utah, Virginia and Wisconsin
- Medical device recall Vancomycin Screen Agar The affected expired lots of product may have exhibited breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf… Class IIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Enterococcus Screen Agar QUAD Plate The affected expired lots of product may have exhibited breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf… Class IIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Total Toe Instrument Kit, Labeled in part: “Instrument Set, 15mm Toe, Dorsal Flange Combi” An oversight in the implementation of the design change record resulted in outdated components being shipped to customers. Class IIFDA’s classDec 30, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereCalifornia, Pennsylvania and West Virginia
- Medical device recall Dressol-X, Radiopaque D-502 Rainbow Specialty & Health Products initiated a field action for Dressol-X and Dressit-X because the labeling does not currently list the percentage of drug… Class IIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dressit-X, Radiopaque D-545 Rainbow Specialty & Health Products initiated a field action for Dressol-X and Dressit-X because the labeling does not currently list the percentage of drug… Class IIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VAPR¿ TRIPOLAR 90” Degree Suction Electrodes (Model/Catalog No: 225028) Mitek identified that on VAPR Tripolar 90 Degree Suction Electrode the ablation and coagulation buttons are colored incorrectly. Class IIFDA’s classDec 30, 2015in FDA’s Enforcement Report11 statesnamed in where it went PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Florida, Kentucky, Minnesota, Mississippi, North Dakota, New Jersey, New Mexico and Texas
- Medical device recall Synaptive Medical BrightMatter Navigator System (Guide System) Out of tolerance for radio frequency emissions. Class IIFDA’s classDec 30, 2015in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereFlorida, Illinois, Louisiana, Washington and Wisconsin
- Medical device recall Artis systems with large display from Siemens Medical Solutions USA, Inc Due to improper soldering in a limited number of large display bypass module components of a specific production lot, a loss of video signal could potentially… Class IIFDA’s classDec 30, 2015in FDA’s Enforcement Report12 statesnamed in where it went PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Illinois, Massachusetts, Michigan, North Dakota, New Jersey, Ohio, Tennessee, Texas and Wisconsin
- Medical device recall MicroCutter Xchange 30 Blue Cartridge, FG-025320 Cardica, Inc. Class IIFDA’s classDec 30, 2015in FDA’s Enforcement Report16 statesnamed in where it went PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Florida, Georgia, Iowa, Massachusetts, Maryland, Minnesota, New York, Ohio, Pennsylvania, Rhode Island, Texas, Washington and Wisconsin
- Medical device recall MicroCutter Xchange 30 Blue Curved Tip Cartridge Cardica, Inc. Class IIFDA’s classDec 30, 2015in FDA’s Enforcement Report16 statesnamed in where it went PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Florida, Georgia, Iowa, Massachusetts, Maryland, Minnesota, New York, Ohio, Pennsylvania, Rhode Island, Texas, Washington and Wisconsin
- Medical device recall 1 Step 12 Panel Cup Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall 10-Panel Pipette Drug Screen Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall 11 Panel Dip Card (OPI 300) w/Adult Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
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.”
Your shortlist0 of 4
Add one more to compare.