Medical devices, 2014
Shortlist up to four to read them side by side.
3,059 medical device recalls FDA’s Enforcement Report published in 2014, 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 7, 2026.
3,059of 3,059 medical device recallsshown with your filters
The list
- Medical device recall ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.0 The tracheal tube can kink during patient use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 5, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.5 The tracheal tube can kink during patient use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 5, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.0 The tracheal tube can kink during patient use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 5, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.5 The tracheal tube can kink during patient use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 5, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.0 The tracheal tube can kink during patient use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 5, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.5 The tracheal tube can kink during patient use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 5, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 9.0 The tracheal tube can kink during patient use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 5, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 6.0 The tracheal tube can kink during patient use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 5, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 6.5 The tracheal tube can kink during patient use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 5, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 7.0 The tracheal tube can kink during patient use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 5, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 7.5 The tracheal tube can kink during patient use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 5, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 8.0 The tracheal tube can kink during patient use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 5, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 8.5 The tracheal tube can kink during patient use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 5, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 9.0 The tracheal tube can kink during patient use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 5, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators to conform radiation… It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Florida, Georgia, Iowa, Missouri, North Dakota, New York, Oklahoma, Rhode Island, Texas, Virginia and Washington named
- Medical device recall ANGIOGRAPHY PACK Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedMar 5, 2014ClassClass IStatusTerminatedWhereNationwide, and Alabama, California, Florida, Illinois, Louisiana, Ohio and Virginia named
- Medical device recall ANGIO PACK #2 Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedMar 5, 2014ClassClass IStatusTerminatedWhereNationwide, and Alabama, California, Florida, Illinois, Louisiana, Ohio and Virginia named
- Medical device recall HEART CATH CUSTOM PACK Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedMar 5, 2014ClassClass IStatusTerminatedWhereNationwide, and Alabama, California, Florida, Illinois, Louisiana, Ohio and Virginia named
- Medical device recall CATH LAB CUSTOM PACK Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedMar 5, 2014ClassClass IStatusTerminatedWhereNationwide, and Alabama, California, Florida, Illinois, Louisiana, Ohio and Virginia named
- Medical device recall CATH TRAY; REF: DYNJ41101; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060;… Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedMar 5, 2014ClassClass IStatusTerminatedWhereNationwide, and Alabama, California, Florida, Illinois, Louisiana, Ohio and Virginia named
- Medical device recall CATH PACK; REF: DYNJ41103; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060;… Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedMar 5, 2014ClassClass IStatusTerminatedWhereNationwide, and Alabama, California, Florida, Illinois, Louisiana, Ohio and Virginia named
- Medical device recall STERILE SAMPLE BUILD Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedMar 5, 2014ClassClass IStatusTerminatedWhereNationwide, and Alabama, California, Florida, Illinois, Louisiana, Ohio and Virginia named
- Medical device recall STERILE SAMPLE CATH LAB PACK Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedMar 5, 2014ClassClass IStatusTerminatedWhereNationwide, and Alabama, California, Florida, Illinois, Louisiana, Ohio and Virginia named
- Medical device recall STERILE SAMPLE BUILD Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedMar 5, 2014ClassClass IStatusTerminatedWhereNationwide, and Alabama, California, Florida, Illinois, Louisiana, Ohio and Virginia named
- Medical device recall CATH ANGIOGRAPHY DRAPE PACK Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedMar 5, 2014ClassClass IStatusTerminatedWhereNationwide, and Alabama, California, Florida, Illinois, Louisiana, Ohio and Virginia named
- Medical device recall CATH PACK; REF: DYNJ40904; Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060;… Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedMar 5, 2014ClassClass IStatusTerminatedWhereNationwide, and Alabama, California, Florida, Illinois, Louisiana, Ohio and Virginia named
- Medical device recall Reflection Interfit Shell, 52 MM OD, 3 HOLE Inner spherical radius of the shell is undersized. Class IIFDA’s classMar 5, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereFlorida and New Jersey
- Medical device recall Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System Modification of the bacterial overflow guard (filter) and related changes to product labeling. Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and West Virginia named
- Medical device recall Renasys EZ PLUS, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System Modification of the bacterial overflow guard (filter) and related changes to product labeling. Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and West Virginia named
- Medical device recall VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System Sterility of medical devices intended for use in surgical procedures may be compromised. Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Louisiana, New Jersey and New York named
- Medical device recall GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant Resuscitation System Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedMar 5, 2014ClassClass IStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, 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, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe Stand-alone Infant Resuscitation… Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedMar 5, 2014ClassClass IStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, 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, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall GE Healthcare - Giraffe¿ and Panda¿ iRes Infant Warmer Product Usage: The infant radiant warmers provide… Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedMar 5, 2014ClassClass IStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, 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, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall NxStage PureFlow-B Solution Mislabeled product. Class IIFDA’s classMar 5, 2014in FDA’s Enforcement Report6 statesnamed in where it went PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Idaho, New York and Texas
- Medical device recall Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT, BrightView X & BrightView… Three problems were reported to the firm: When positioning for a relative 180 degree non circular acquisition the second (bottom) detector was not positioned… Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, 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, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall pCO2 D788 Membranes RADIOMETER has become aware that some D788 pCO2 membranes can cause biased measurement results on patient results as well as QC results. Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, 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, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012 Complaints were received regarding Quality Control (QC) shifts with Pseudocholinesterase (PCHE) and imprecision during PCHE calibration with the Dimension… Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PFC SIGMA Cruciate Retaining (CR) Knee implant femoral devices were found to have anomalous microstructure. Class IIFDA’s classMar 5, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, Iowa and Kentucky
- Medical device recall GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option (WDR1) GE Healthcare has recently become aware of a software issue associated with patient selection from the worklist on your WDR1(Precision 500D and Proteus XR/a… Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Trabecular Metal” Reverse Shoulder System As a result of complaints for disassociation of the TM Reverse Glenosphere from the Baseplate, Zimmer updated the related surgical technique and released a… Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens Artis zee Ceiling Systems During the lifetime of Artis zee Ceiling systems, there is an increased wear due to potential sub-optimal cable guidance that can lead to cable damage. Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Specialty Straight Static Inserter Assembly Product Usage: This instrument is a part of the Navigator product… Stryker has received complaints from customers relating to fracture along the weld that binds the handle to the shaft of the static inserter. Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS Chemistry Products Na+ Slides Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to false positive serum and plasma sample results. Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, 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, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Chemistry Products Calibrator Kit 2 Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to false positive serum and plasma sample results. Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, 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, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and Nitinol, Orthofix Inc. There is a possibility that the locking mechanism of the Azure Anterior Cervical Plate may fracture during or after implantation. Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall HeartStart MRx Monitor/Defibrillator A component of the MRx Processor Board may be susceptible to damage from electrostatic discharge (ESD), which can disrupt ECG and SpO2 functionality leading to… Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, 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, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequency (LMF) DC… Instrumentarium Dental has delivered a number of FOCUS 3.0 Intraoral X-ray units in November 2013 with a potential flaw in the mounting hardware. Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, Georgia, Illinois, Kentucky, Maryland, Montana, North Carolina, Nevada, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall 00434811113, REF I4348-111-13 Zimmer Trabecular Metal Shoulder Humeral Stem 48 Degrees 11 mm Stem Diameter… This single manufacturing lot has the potential for the bond strength between the Trabecular Metal material and substrate to be below the minimum required… Class IIFDA’s classMar 5, 2014in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedMar 5, 2014ClassClass IIStatusTerminatedWhereIllinois
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.