Medical devices, 2021
Shortlist up to four to read them side by side.
2,303 medical device recalls FDA’s Enforcement Report published in 2021, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 5, 2026.
2,303of 2,303 medical device recallsshown with your filters
The list
- Medical device recall Univation X System Tray Sysem knee implant devices as follows: Tray Number/Set Name/Set Number NM1090R… Malfunction- loosening of the implant resulting in a potential revision surgery Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator’s Manual and the OLO software Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedSep 29, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Florida, Massachusetts, Minnesota, Missouri, New York, Ohio, Texas, Virginia and Washington named
- Medical device recall DuoDERM CGF Dressing 10x10CM There is a potential for open seals which can compromise sterility. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 29, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall 10 ga ARS Decompression Needle The device includes the incorrect Instructions for Use. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 29, 2021ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog A119216M, SureStep” Foley Tray, Lubri-Sil”, Urine Meter, Temperature Sensing Dual, StatLock”… There is potential for packaging defects that may impact the sterile barrier. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Catalog A300314A, SureStep” Foley Tray, Bardex” I.C., Complete Care”, Drainage Bag, StatLock” Stabilization… There is potential for packaging defects that may impact the sterile barrier. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Catalog A300316A, SureStep” Foley Tray, Bardex” I.C., Complete Care”, Drainage Bag, StatLock” Stabilization… There is potential for packaging defects that may impact the sterile barrier. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Catalog A300318A, SureStep” Foley Tray, Bardex” I.C., Complete Care”, Drainage Bag, StatLock” Stabilization… There is potential for packaging defects that may impact the sterile barrier. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Catalog A303316A, SureStep” Foley Tray, Bardex” I.C., Complete Care”, Urine Meter, StatLock” Stabilization… There is potential for packaging defects that may impact the sterile barrier. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Catalog A303318A, SureStep” Foley Tray, Bardex” I.C., Complete Care”, Urine Meter, StatLock” Stabilization… There is potential for packaging defects that may impact the sterile barrier. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Catalog A319416AM, SureStep” Foley Tray, Bardex” I.C., Complete Care”, Urine Meter, Temperature Sensing,… There is potential for packaging defects that may impact the sterile barrier. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Catalog A399400A, SureStep” Foley Tray, Add-a-Foley, Complete Care”, Drainage Bag, StatLock” Stabilization… There is potential for packaging defects that may impact the sterile barrier. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Catalog A800061, SureStep” Foley Tray, Bard LubricathTM Foley Catheter Tray There is potential for packaging defects that may impact the sterile barrier. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Catalog A800360, SureStep” Foley Tray, Bard LubricathTM Foley Catheter Tray There is potential for packaging defects that may impact the sterile barrier. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Catalog A800361, SureStep” Foley Tray, Bard LubricathTM Foley Catheter Tray There is potential for packaging defects that may impact the sterile barrier. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Catalog A800365, SureStep” Foley Tray, Bard LubricathTM Foley Catheter Tray There is potential for packaging defects that may impact the sterile barrier. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Catalog A897514, SureStep” Foley Tray, Silicone, Drainage Bag, StatLock” Stabilization Device There is potential for packaging defects that may impact the sterile barrier. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Catalog A899916, SureStep” Foley Tray, Lubricath”, Drainage Bag, StatLock” Stabilization Device There is potential for packaging defects that may impact the sterile barrier. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Catalog A902616, SureStep” Foley Tray, Bardex” I.C., Lubricath”, Urine Meter There is potential for packaging defects that may impact the sterile barrier. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Catalog A902916, SureStep” Foley Tray, Lubricath”, Urine Meter, StatLock” Stabilization Device There is potential for packaging defects that may impact the sterile barrier. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Catalog A943216, SureStep” Foley Tray, Lubricath”, Urine Meter, StatLock” Stabilization Device There is potential for packaging defects that may impact the sterile barrier. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Catalog A319516AM, SureStep” Foley Tray, Lubri-Sil” I.C., Temperature Sensing Complete Care”, Drainage Bag,… There is potential for packaging defects that may impact the sterile barrier. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Catalog A902416, SureStep” Foley Tray, Silicone, Urine Meter, StatLock” Stabilization Device There is potential for packaging defects that may impact the sterile barrier. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Catalog A303416A, SureStep” Foley Tray, Lubri-Sil” I.C., Temperature Sensing Complete Care”, Drainage Bag,… There is potential for packaging defects that may impact the sterile barrier. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Catalog A942216, SureStep” Foley Tray, Bard LubricathTM, Urine Meter, StatLock” Stabilization Device There is potential for packaging defects that may impact the sterile barrier. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 22, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 22, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 22, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 22, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 22, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AMSORB PLUS PREFILLED G-CAN 1.0L Some devices may be associated with high and unexpected resistance to gas flow during clinical use, impacting or preventing adequate ventilation of an… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 22, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall The Hero Model 100 (H-100) is a system consisting of a smart pill dispenser and a medication management app. Due to dispenser prompting for a missed dose that had already been dispensed Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 22, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall cobas infinity central lab running software version 3.01.03 through 3.02.08 Under specific circumstances created by the user, the cobas e flow test results could be replaced by an automatic result sent to the lab LIS. Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 22, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment… Potential for data loss when using the contouring or patient marking workflow when editing a structure set after saving and reopening a study, resulting in an… Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 22, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall syngo.CT VA20A, VA30A and VA40A in: syngo.via RT Image Suite / Sim&Go SOMATOM go.Now SOMATOM go.Up SOMATOM… Potential for data loss when using the contouring or patient marking workflow when editing a structure set after saving and reopening a study, resulting in an… Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 22, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MR MAGNETOM Systems with RT Image Suite with syngo MR VA20A, VA30A and VA31A with license SW-Key… Potential for data loss when using the contouring or patient marking workflow when editing a structure set after saving and reopening a study, resulting in an… Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 22, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet… Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 22, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K,… Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 22, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Potassium Hydroxide 10% (KOH 10%) A lot of KOH 10% was made with Hydrogen Peroxide 3% instead of KOH 10%. Class IIFDA’s classSep 22, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedSep 22, 2021ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Kentucky, Maine, North Carolina, New York and South Carolina
- Medical device recall Verigene EP Amplification Reagent Kit Test There is potential for false positive results. Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 22, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 “declined to issue” The kit does not have an emergency use authorization (EUA). Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedSep 22, 2021ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Texas and Wisconsin named
- Medical device recall Configura Advance Chair The firm has identified a potential for the backrest to become detached from the chair. Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedSep 22, 2021ClassClass IIStatusOngoingWhereNationwide, and Alabama, Florida, Illinois, Minnesota, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania and South Carolina named
- Medical device recall BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total… Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedSep 22, 2021ClassClass IIStatusOngoingWhereNationwide, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BD SmartSite ‘Y’ Extension Set 2 Needle-Free Valves Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total… Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedSep 22, 2021ClassClass IIStatusOngoingWhereNationwide, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BD Gravity Burette Set 60 DROP 1.2 MF 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total… Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedSep 22, 2021ClassClass IIStatusOngoingWhereNationwide, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BD Syringe Set 20 DP MIC TBG 0.2MF CKV Anti-Siphon SmartSite VLV Sensing Disc Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total… Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedSep 22, 2021ClassClass IIStatusOngoingWhereNationwide, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BD BURETTE GRAVITY SET 60 DROP 2 Smartsite VALVES VENTED/NONVENTED Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total… Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedSep 22, 2021ClassClass IIStatusOngoingWhereNationwide, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSite Port (Burette) SmartSite… Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total… Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedSep 22, 2021ClassClass IIStatusOngoingWhereNationwide, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming 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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