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 6, 2026.
2,495of 2,495 medical device recallsshown with your filters
The list
- Medical device recall ADVIA Chemistry Systems Drug Calibrator I Incorrect calibrator lot values were assigned for ADVIA Chemistry Systems Drug Calibrator I, lot 3JD018, for the ADVIA Chemistry Systems Phenytoin 2 (PHNY_2)… Class IIFDA’s classApr 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations The firm is recalling Rheo Knee bionic prosthetic due to it being discovered during an internal audit of the service line that devices were released for… Class IIFDA’s classApr 1, 2015in FDA’s Enforcement ReportTennesseethe one state its words name PublishedApr 1, 2015ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall Coblator II System, 120V The recalling firm was notified by the contract manufacturer that they had reversed the L2, L3, L4, or L5 components on the P/N09010 RoHS boards of the… Class IIFDA’s classApr 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedApr 1, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Iowa, Nebraska, New York, Oklahoma, South Dakota and Tennessee named
- Medical device recall Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile The TCS Straight Hexlobular #6 Drivers (5210-1004) tip sheared off during use in procedures that involved patients with dense bones. Class IIFDA’s classApr 1, 2015in FDA’s Enforcement Report18 statesnamed in where it went PublishedApr 1, 2015ClassClass IIStatusTerminatedWhereArizona, California, Connecticut, Florida, Georgia, Idaho, Illinois, Kentucky, Maryland, Missouri, Nevada, New York, Ohio, Oklahoma, Oregon, Texas, Utah and Wisconsin
- Medical device recall NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed. Class IIFDA’s classApr 1, 2015in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedApr 1, 2015ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouches with Tyvek header Devices were not sterilized Class IIFDA’s classApr 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedApr 1, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Missouri, Mississippi, North Carolina, New Jersey, New York, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primary packaging is 12 pouches with… Devices were not sterilized Class IIFDA’s classApr 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedApr 1, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Missouri, Mississippi, North Carolina, New Jersey, New York, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software There may be an existing dark current phenomenon on ARTISTE LINAC in combination with IMRT or mARC treatments using unflat beams. Class IIFDA’s classMar 25, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedMar 25, 2015ClassClass IIStatusTerminatedWhereNew York, Utah and Wisconsin
- Medical device recall Elekta Precise Treatment Table It is possible to position the Treatment Table with errors greater than 5mm and no inhibits are displayed, if the positional sensors are not correctly… Class IIFDA’s classMar 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ML 7090 Calibrated LASIK Blade (CLB) The ML 7090 Calibrated LASIK Blade (CLB) will not fit into the AMO Amadeus Metal Blade Holder. Class IIFDA’s classMar 25, 2015in FDA’s Enforcement Report4 statesnamed in where it went PublishedMar 25, 2015ClassClass IIStatusTerminatedWhereAlabama, California, Georgia and Tennessee
- Medical device recall MiniCap with Povidone-Iodine Solution Product may have separating or protruding sponges Class IIFDA’s classMar 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2015ClassClass IIStatusCompletedWhereNationwide
- Medical device recall GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC Potential failure of the caster mounting hardware, which may result in the ventilator falling/tipping (overbalancing). Class IIFDA’s classMar 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Bard Poly Midline 3F Full Tray… Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Class IIFDA’s classMar 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerLoc Port Access Kit 19G x… Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Class IIFDA’s classMar 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: SafeStep Port Access Kit 22G x… Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Class IIFDA’s classMar 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerGlide Midline Catheter… Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Class IIFDA’s classMar 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Groshong Midline Bard MYPICC… Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Class IIFDA’s classMar 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065 Clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end of the Steerable Sheath, outside of the patients bodies. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 25, 2015ClassClass IStatusTerminatedWhereNationwide, and Iowa and North Carolina named
- Medical device recall Medstream 81” Several complaints regarding the IV sets leaking at the Y site. Class IIFDA’s classMar 25, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedMar 25, 2015ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Illinois, Massachusetts, Ohio and Texas
- Medical device recall Puritan absorbent foam tipped applicator Shaft breaks so that adequate patient specimen sample cannot be obtained. Class IIFDA’s classMar 25, 2015in FDA’s Enforcement Report4 statesnamed in where it went PublishedMar 25, 2015ClassClass IIStatusTerminatedWhereGeorgia, Maine, Mississippi and North Carolina
- Medical device recall GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all configurations GE Healthcare has recently become aware of a potential safety issue due to a collimator falling off a VG system during a Quality Control check, while the… Class IIFDA’s classMar 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedMar 25, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New York, Oklahoma, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection and Alarms) Intended for intra… An issue has been identified with Passport V Monitors invasive blood pressure function (IBP) which may provide an incorrect IBP measurement Class IIFDA’s classMar 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number… For certain lots, the incorrect raw material of annealed 17-4PH Stainless Steel was used instead of the correct material of heat-treated 304 Stainless Steel. Class IIFDA’s classMar 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens LANTIS Oncology Information System Servers There is a potential safety risk when using LANTIS server software with operating systems with which it has not been validated or released which can lead to an… Class IIFDA’s classMar 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Triathlon Distal Capture Assembly Potential for weld disassociation of the cross pin, which could lead to loose or disassociated trigger mechanism on the Distal Capture Assembly. Class IIFDA’s classMar 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 25, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall TactiSys Quartz Pack, PN-004 400 A configuration update needs to be done on TactiSys to appropriately recognize all TactiCath catheters. Class IIFDA’s classMar 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedMar 25, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Hampshire, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall GE Healthcare, Treadmill T2100 and Treadmill T2000 with power cord Potential safety issue due to improper assembly associated with the power cords of T2100 and T2000 Treadmills. Class IIFDA’s classMar 25, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 25, 2015ClassClass IIStatusTerminatedWhereDistrict of Columbia and Puerto Rico
- Medical device recall CADD” Medication Cassette Reservoir, 50mL Smiths Medical has become aware of an issue with specific lots of 50mL CADD” Medication Cassette Reservoirs ( Cassette ). Class IIFDA’s classMar 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedMar 25, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides are intended… Images belonging to a different patient were used for the production of the patient specific surgical guide. Class IIFDA’s classMar 25, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 25, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall LP Rotate Foot System prosthetic device for fitting lower extremity amputations. -Low profile foot module… The threads of the outer tube of the shock module of LP Rotate are too short, resulting in insecure assembly. Class IIFDA’s classMar 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall N Latex IgM; In-vitro diagnostic reagent for the quantitative determination of IgM in human cerebrospinal… Complaints have been confirmed on failed proficiency testing due to serum samples recovering too low when using some N Latex IgM reagent kit lots 44018, 44019… Class IIIFDA’s classMar 25, 2015in FDA’s Enforcement Report7 statesnamed in where it went PublishedMar 25, 2015ClassClass IIIStatusTerminatedWhereCalifornia, Colorado, Florida, North Carolina, New York, Ohio and Utah
- Medical device recall Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves Cases of Cure Sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes labeled with part number 4500 which fit 7mm and 8mm tips. Class IIFDA’s classMar 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The HomeChoice Pro APD System is a peritoneal dialysis system The occluder in affected devices 1) may have sharp edges that could cut the pneumatic tubing that connects the occluder blade to the manifold causing an… Class IIFDA’s classMar 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedMar 25, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arkansas, Arizona, California, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Crea A and B membranes Negative drift on QC during in-use lifetime of CREA membranes can be observed. Class IIFDA’s classMar 25, 2015in FDA’s Enforcement Report27 statesnamed in where it went PublishedMar 25, 2015ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall LeMaitre Vascular Tumescent Catheter Inversion (TCI) System Mislabeled with an incorrect expiration date Class IIIFDA’s classMar 25, 2015in FDA’s Enforcement Report7 statesnamed in where it went PublishedMar 25, 2015ClassClass IIIStatusTerminatedWhereCalifornia, Colorado, Kansas, Minnesota, Utah, Washington and Wisconsin
- Medical device recall Transonic Hemodialysis Monitor Customer unable to obtain measurements due to the device seeing no flow or irrelevant flow condition during dialysis procedures. Class IIFDA’s classMar 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Symbia E is a multi-purpose SPECT system used to detect or image the distribution of radionuclides in the… Radial motor drives replaced during a customer service action were incorrectly assembled backwards. Class IIFDA’s classMar 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedMar 25, 2015ClassClass IIStatusTerminatedWhereNationwide, and 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, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall E.CAM emission computed tomography system used to detect or image the distribution of radionuclides in the… Radial motor drives replaced during a customer service action were incorrectly assembled backwards. Class IIFDA’s classMar 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedMar 25, 2015ClassClass IIStatusTerminatedWhereNationwide, and 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, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall CooperSurgical Infant Heel Gel Warmers, P/N 20418 CooperSurgical The Infant Heal Warmer, P/N 2440 To provide… Products without expiration date have the remote potential for minor burn Class IIFDA’s classMar 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fisher Brand Gel Infant Heel Gel Warmers Products without expiration date have the remote potential for minor burn Class IIFDA’s classMar 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MediChoice WarmGel Infant Heel Warmer Products without expiration date have the remote potential for minor burn Class IIFDA’s classMar 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NovaPlus Brand Warm Gel Infant Heel Gel Warmer Products without expiration date have the remote potential for minor burn Class IIFDA’s classMar 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Juno DFR X-ray system The system does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control… Class IIFDA’s classMar 18, 2015in FDA’s Enforcement Report21 statesnamed in where it went PublishedMar 18, 2015ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Iowa, Illinois, Indiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, New York, Ohio, Pennsylvania, Tennessee, Texas and Utah
- Medical device recall Pressure IQ Evolve Mattress The firm received complaints regarding multiple mattresses were showing failures resulting in pressure ulcers. Class IIFDA’s classMar 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GE Healthcare Proteus XR/a with wall stand Potential breakage of the steel cable which supports the bucky device in certain wall stands of Proteus XR/a X-ray imaging systems. Class IIFDA’s classMar 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedMar 18, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall EVOLUTION MP TIBIAL BASE Some units of the EVOLUTION Tibial Base was affected by a casting tool issue which caused varying retaining wall thickness and keel offset in the finished… Class IIFDA’s classMar 18, 2015in FDA’s Enforcement Report8 statesnamed in where it went PublishedMar 18, 2015ClassClass IIStatusTerminatedWhereAlabama, Arizona, Iowa, Idaho, Kansas, Missouri, Texas and West Virginia
- Medical device recall Apollo (cold) Laser Desktop Control Units Control units were equipped with an internal mounting kit that does not meet medical safety standards, and are conductive, increasing the risk of electric… Class IIFDA’s classMar 18, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedMar 18, 2015ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Georgia, Iowa, Illinois, Indiana, Kansas, Michigan, Minnesota, Missouri, New York, Ohio, Oregon, Pennsylvania, Utah and Washington
- Medical device recall Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic Models: 712210, 712211 Improper installation of Tube arm, and Wall stand may cause it to fall down, Improper installation of table may cause it to float. Class IIFDA’s classMar 18, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 18, 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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