Medical devices, 2016
Shortlist up to four to read them side by side.
3,246 medical device recalls FDA’s Enforcement Report published in 2016, 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.
3,246of 3,246 medical device recallsshown with your filters
The list
- Medical device recall Performance-LOAD Ambulance Cot Fastener Stretcher, Wheeled Stryker Medical initiated a voluntary recall of Stryker Performance-LOAD Cot Fasteners due to complaints that fastening system may not have been securely… Class IIFDA’s classDec 21, 2016in FDA’s Enforcement Report44 statesnamed in where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, West Virginia and Wyoming
- Medical device recall BD Spinal Anesthesia Tray The BD Spinal Anesthesia Tray is intended for use by professional anesthesiologists… BD is conducting a voluntary product recall of the BD Spinal Anesthesia Tray, Cat (Ref) 405671, lot B01K089D since a very low number of trays are incorrectly… Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall McKesson Powder Free Vinyl Exam Gloves A container of McKesson vinyl gloves that failed the FDA leak test was inadvertently distributed. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportWashingtonthe one state its words name PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereWashington
- Medical device recall SOMATOM Definition AS System, x-ray, tomography, computed Intended to produce cross-sectional images of the… Software update that provides software and firmware bug-fixes to improve system performance Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SOMATOM Definition Flash System, x-ray, tomography, computed Intended to produce cross-sectional images of… Software update that provides software and firmware bug-fixes to improve system performance Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SOMATOM Definition Edge System, x-ray, tomography, computed Intended to produce cross-sectional images of the… Software update that provides software and firmware bug-fixes to improve system performance Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD 23 G x .75 in BD has received multiple reports of units associated with the 23 G x .75 in. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Harmony Insight Diagnostic Monitor Support System - 100 Spring Arm (EMS) The system is intended for use in… The Drager Pendula spring arm device has a set of screws located on the spring arm that were not properly secured with Loctite and may become loose. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, Florida, Illinois, Kentucky, Michigan, Missouri, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Washington and West Virginia named
- Medical device recall Perkin Elmer RoboRack 25ul, Clear, Non-Conductive, Filter Tips, Pre-sterilized Filter Tips molded incorrectly and may not seal to the Varispan tip adaptor properly causing inaccurate aspiration and dispensing Class IIFDA’s classDec 21, 2016in FDA’s Enforcement Report7 statesnamed in where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereCalifornia, Iowa, Massachusetts, New York, Oregon, Pennsylvania and Washington
- Medical device recall ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable, Contents: Five Mislabeling of the “expiration date”. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement Report12 statesnamed in where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereCalifornia, Florida, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Ohio, Pennsylvania, Texas, Virginia and West Virginia
- Medical device recall Cellfina Prep Pack It was discovered that a non-sterile vacuum tube is supplied within the pack, although the Instructions for Use (IFU) describe the use of a sterile vacuum tube… Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall LightMix¿ Zika rRT-PCR Test The LightMix¿ Zika rRT-PCR Test is a real-time RT-PCR test intended for the… The LightCycler¿ 480 algorithm used for the LightMix¿ Zika rRT-PCR Test, EUA (catalog number 07987897001) occasionally (~1% of the time) calls a positive… Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate causing the packages to open and compromise sterility of the… Class IIFDA’s classDec 21, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNorth Carolina and Texas
- Medical device recall Metzenbaum Scissors 7 , Curved, Sterile The Metzenbaum Scissors 7 , Curved Curved are single-use sterile… The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate causing the packages to open and compromise sterility of the… Class IIFDA’s classDec 21, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNorth Carolina and Texas
- Medical device recall Ecolab, Microtek Rolled Probe Cover PC0907NB The reason for the recall is that the inner carton box of the Rolled Probe Cover PC0907NB has the incorrect expiration date (2015-10-01) on the label while the… Class IIIFDA’s classDec 21, 2016in FDA’s Enforcement Report7 statesnamed in where it went PublishedDec 21, 2016ClassClass IIIStatusTerminatedWhereCalifornia, Florida, Michigan, New Jersey, Texas, Utah and Virginia
- Medical device recall HF Cable WA00014A, Endoscopic electrosurgical unit and accessories Software malfunction that results in incorrect generation or display of error codes. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GE Healthcare, Avance, Avance CS2, Amingo. GE Healthcare has become aware of a potential safety issue where certain Avance CS2, Avance and Amingo anesthesia devices can transition to a System… Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Covidien Precision Specimen Container- 4 oz Sterility of the outer surface of the container compromised due to packaging defect. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ultrasound Video Bronchoscope The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical… The EB-1970UK Ultrasound Video Bronchoscope shipped between the clearance date of April 2014 and September 2015 contained the Operation and Reprocessing IFUs… Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile. Defects: Product may be discolored and brittle resulting in the inability of the user to don the gloves without tearing. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement Report13 statesnamed in where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Iowa, Indiana, Louisiana, Massachusetts, Minnesota, Montana, New Mexico, Oregon, Texas and Utah
- Medical device recall Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and… The devices wings may become partially detached from the EFx Shield during use. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall INOVO Purefill Oxygen Compressor Device can fail during operation. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Connecticut, Florida, Iowa, Kansas, Kentucky, Maryland, Michigan, Minnesota, Missouri, Nebraska, New Jersey, Nevada, New York, Ohio, Rhode Island, South Carolina, Tennessee, Texas, Utah and Washington named
- Medical device recall The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor… Customer complaint was received relating to a LifePak15 device that would power on then power down unexpectedly after a short period of use. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls containing BNP, CK MB… An internal real-time stability monitoring program revealed decreased recovery of myoglobin (-20% bias) for Randox Immunoturbidimetric and Siemens Centaur… Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Ceramax Skin Barrier Cream Firm became aware that professional samples of Ceramax are not meeting stability standards set for the product. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall WECK Visistat 35W, Disposable Skin Stapler Sterility Deficiency: The packages are not sealed properly and thus the sterility is not assured. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Reprocessed Xcel Bladeless Trocar (H12LP) An increase in reports indicating that the reprocessed H12LP Trocar adjustable plug may break in the packaging or during use. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to make the housing resection for… It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IVEA 500A Intended for Med-Surg patient care. The dowel pin could potentially slip out of its press fit, resulting in the product potentially slumping to one side which could cause the patient to stumble. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall MicroScan LabPro Data Management System Beckman Coulter has received and confirmed reports of an intermittent and unexpected behavior when loading new panels into a WalkAway instrument using LabPro… Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Updated Natus neoBLUE blanket LED Phototherapy Systems The firm sent the Technical Bulletin to consignees who received the reliability updated neoBLUE blanket LED Phototherapy Systems between March 2016 to August… Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin and West Virginia named
- Medical device recall Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy neoBLUE blanket LED Phototherapy System distributed since release of the product in 2011 is recalled due to customer complaints regarding discoloration/… Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Multi-Med Single Lumen Catheters The kits contain Multi-Med Single Lumen Catheters that have a potential for excess material to remain at the tip of the catheter from the manufacturing process. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall 5000 Series Freedom Drivers The Main Printed Circuit Board Assembly (PCBA) of the affected Freedom Drivers may fail and cause the Freedom Driver to stop functioning without visual or… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 14, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 14, 2016ClassClass IStatusTerminatedWhereArizona and Virginia
- Medical device recall Olympus Scientific Solutions Americas Corporation ( OSSA ) Possible unintentional x-ray emission after users attempt early termination of the sequence. Class IIFDA’s classDec 14, 2016in FDA’s Enforcement Report16 statesnamed in where it went PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Minnesota, New Jersey, Ohio, Pennsylvania, South Carolina, Texas, Virginia and Washington
- Medical device recall SOMATOM Force, System x-ray, tomography, computed Siemens is providing software update version VA50A_SP3 to address the software bugs that were identified through normal field monitoring and the Global… Class IIFDA’s classDec 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Brilliance 64 728231 Computed Tomography X-ray systems intended to produce cross-sectional images of the body… Software error due to the filament on timer Class IIFDA’s classDec 14, 2016in FDA’s Enforcement Report46 statesnamed in where it went PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, 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, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Brilliance 64 728232 Computed Tomography X-ray systems intended to produce cross-sectional images of the body… Software error due to the filament on timer Class IIFDA’s classDec 14, 2016in FDA’s Enforcement Report46 statesnamed in where it went PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, 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, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Ingenuity Core 728321 Computed Tomography X-ray systems intended to produce cross-sectional images of the… Software error due to the filament on timer Class IIFDA’s classDec 14, 2016in FDA’s Enforcement Report46 statesnamed in where it went PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, 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, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Ingenuity Core 128 728323 Software error due to the filament on timer Class IIFDA’s classDec 14, 2016in FDA’s Enforcement Report46 statesnamed in where it went PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, 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, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Ingenuity CT 728326 Computed Tomography X-ray systems intended to produce cross-sectional images of the body… Software error due to the filament on timer Class IIFDA’s classDec 14, 2016in FDA’s Enforcement Report46 statesnamed in where it went PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, 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, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Elana Surgical KitHUD The Elana Surgical KitHUD, when connected to the Spectranetics Xenon-Chloride Laser Elana has issued this Field Action to voluntarily remove specific serial numbers of our Elana Surgical KitHUD due to potentially compromised integrity of the… Class IIFDA’s classDec 14, 2016in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereNew York
- Medical device recall Aequalis Fx2 implant parts and instrument trays Tornier is conducting a recall on Aequalis Fx2 ( implant parts and instrument trays) due to reports of dislocations of the poly insert and the stem. Class IIFDA’s classDec 14, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereCalifornia, Michigan and Texas
- Medical device recall Model 37751 Recharger Product Usage: The Medtronic 37751 Recharger is a hand-held device used to charge the… Medtronic has identified an increased number of complaints from customers involving reports of Rechargers (Medtronic Model 37751 Recharger, which is included… Class IIFDA’s classDec 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
- Medical device recall 3M Universal Electrosurgical Pad 3M is recalling Universal Electrosurgical Pads because a report of an unintended material (process liner) in the product. Class IIFDA’s classDec 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Florida, Georgia, Idaho, Illinois, Kentucky, North Carolina, New York, Tennessee, Texas and Virginia named
- Medical device recall MANOS EX (CAT#TY-12-101) Product Usage: Carpal Tunnel Release: as a tool for tissue release of the transverse… The firm failed to notify current customers of IFU update/warning. Class IIFDA’s classDec 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, District of Columbia, Georgia, Idaho, Indiana, Maryland, Michigan, South Dakota, Texas, Utah and Virginia named
- Medical device recall LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in Knee Revision Surgery DePuy Orthopaedics, Inc. Class IIFDA’s classDec 14, 2016in FDA’s Enforcement ReportTennesseethe one state its words name PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall UltraSeal XT Plus Clear Refill There was a labeling error with product, UltraSeal XT Plus Clear Refill, Part Number (PN) 565, Lot Number (Lot) BD79T. Class IIFDA’s classDec 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2016ClassClass 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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