Medical devices, 2020
Shortlist up to four to read them side by side.
3,055 medical device recalls FDA’s Enforcement Report published in 2020, 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.
3,055of 3,055 medical device recallsshown with your filters
The list
- Medical device recall VACUETTE Blood Transfer Unit While transferring blood the needle may dislodged and remain in the tube stopper which may cause needle stick injury or blood leakage. Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and… Abbott identified that samples tested for ARCHITECT STAT High Sensitive Troponin I and STAT High Sensitivity Troponin I assays (LN 3P25 and LN 2R98) may show… Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedJun 3, 2020ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Connecticut, Delaware, Florida, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Montana, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Clearview Total Uterine Manipulator (model UM750), The device is labeled in part, “ClearView(R) TOTAL, 7 cm*… An incorrect component used during manufacturing. Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ArtisanTM 70 cm 2 x 8 Surgical Lead Kit The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due… Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Package Contents: Lead Extension Kit… The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due… Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall LinearTM 3-4 50 cm 8 Contact Lead Kit The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due… Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall The LinearTM 3-4 70 cm 8 Contact Lead Kit The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due… Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Precision TM M8 Adapter, 15 cm The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due… Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage: Lead Extensions are… The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due… Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Product Usage: The Deep Brain… The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due… Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Product was not irradiated; therefore, they are not sterile and do not meet product specification. Class IIFDA’s classJun 3, 2020in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereIllinois, Kentucky and Texas
- Medical device recall Cios Alpha Image-Intensified Fluoroscopic X-Ray System The unplugging of the main cable on the monitor trolley from the X10 connector can cause an unsafe electrical voltage (up to 67,6 V DC) at the X10 connector. Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Florida, Illinois, Indiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall Cios Spin Image-Intensified Fluoroscopic X-Ray System The unplugging of the main cable on the monitor trolley from the X10 connector can cause an unsafe electrical voltage (up to 67,6 V DC) at the X10 connector. Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Florida, Illinois, Indiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall Sprotte Needle Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sprotte Needle Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall da Vinci SP Camera Some cameras were found to have residual soil adhered to the tip of the camera after reprocessing which may affect image quality resulting in needing to switch… Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage: The JOURNEY II Uni Resection… The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble. Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usage: The JOURNEY II Uni Resection… The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble. Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an accessory to the compatible… Internal Paddles may wear over time and may not be safe or ready for use, unless the directions in the Instructions for Use (IFU) to perform routine… Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Body Weight Support (BWS) Light The firm discovered a potential manufacturing deviation of the yoke of the Body Weight Support (BWS) Light that in rare occasions may result in the yoke… Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJun 3, 2020ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Kentucky, Massachusetts, Michigan, North Carolina, New Jersey, New York and Ohio named
- Medical device recall ISE Electrolyte Reference Electrolyte reference reagent, used for clinical laboratory testing to determine CO2 in human serum or plasma for diagnosis and treatment of potentially… Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Mississippi, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Philips HeartStart XL Monitor/Defibrillators HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNationwide, and Kentucky, Massachusetts, North Dakota and New York named
- Medical device recall ABL90 FLEX PLUS The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cuvettes, a subcomponent of the optical system which measures ctHb and derivates. Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ABL90 FLEX, model no. 393-090; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are… The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cuvettes, a subcomponent of the optical system which measures ctHb and derivates. Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall FlexLab Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000… The identified problem is an erroneous association between the carrier and the sample tube caused by a communication error between the firmware of the… Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNationwide, and Illinois and New York named
- Medical device recall Accelerator a3600 Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10),… The identified problem is an erroneous association between the carrier and the sample tube caused by a communication error between the firmware of the… Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNationwide, and Illinois and New York named
- Medical device recall Aptio Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000… The identified problem is an erroneous association between the carrier and the sample tube caused by a communication error between the firmware of the… Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNationwide, and Illinois and New York named
- Medical device recall Bridge Occlusion Balloon There is a potential for thrombus formation on balloons prepped and staged in the vasculature for long durations. Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse… Potential presence of elevated endotoxin levels that exceed the specification limit Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hip Products Potential presence of elevated endotoxin levels that exceed the specification limit Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex Series-A Patella 3 Peg, 37 MM… Potential presence of elevated endotoxin levels that exceed the specification limit Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Knee Products: 150414 Orthopedic Salvage System (OSS) Tibial Bearing, 20 MM Standard - Product Usage: Knee… Potential presence of elevated endotoxin levels that exceed the specification limit Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Knee Products: 154335 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D3 154336… Potential presence of elevated endotoxin levels that exceed the specification limit Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM 155326 Knees AGC Knee… Potential presence of elevated endotoxin levels that exceed the specification limit Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Knee Products: 183622 Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 MM 183620 Vanguard Knee System PS… Potential presence of elevated endotoxin levels that exceed the specification limit Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Knee Products: 189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM 189720 Vanguard Knee… Potential presence of elevated endotoxin levels that exceed the specification limit Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Knee Products: 189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM 189422 Vanguard Knee… Potential presence of elevated endotoxin levels that exceed the specification limit Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Knee Products: 183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM EP-183608 Vanguard Knee… Potential presence of elevated endotoxin levels that exceed the specification limit Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Knee Products: 184762 Knees Vanguard Knee System, Series-A Standard Patella, 28 MM Potential presence of elevated endotoxin levels that exceed the specification limit Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Knee Products: US154709 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left… Potential presence of elevated endotoxin levels that exceed the specification limit Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Knee Products: TMJPM-1510 Microfixation Custom Made Device, Left PM-TMJ Potential presence of elevated endotoxin levels that exceed the specification limit Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips HeartStart MRx Monitor/Defibrillators HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Epix latis GRASPER, 5 mm x 35 cm There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to… Class IIFDA’s classJun 3, 2020in FDA’s Enforcement Report43 statesnamed in where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Epix latis GRASPER, 5mm x 45 cm There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to… Class IIFDA’s classJun 3, 2020in FDA’s Enforcement Report43 statesnamed in where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620 There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to… Class IIFDA’s classJun 3, 2020in FDA’s Enforcement Report43 statesnamed in where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Clip Applier Kit There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to… Class IIFDA’s classJun 3, 2020in FDA’s Enforcement Report43 statesnamed in where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall GENTLEWAVE REF: FG-002-0001 The console would continue to run for extended period when the foot pedal was released. Class IIFDA’s classJun 3, 2020in FDA’s Enforcement Report46 statesnamed in where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Panther Fusion Extraction Reagent-S Reagent component included in flu test kit may cause both high background signal in a true negative sample leading to false positive and/or false negative… Class IIFDA’s classJun 3, 2020in FDA’s Enforcement Report15 statesnamed in where it went PublishedJun 3, 2020ClassClass IIStatusOngoingWhereArkansas, California, Florida, Idaho, Illinois, Indiana, Louisiana, New Mexico, New York, Pennsylvania, Texas, Utah, US Virgin Islands, Washington and Wisconsin
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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