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 OSTEOVATION EX, 5CC, IMPACT FORMULA Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall OSTEOVATION IMPACT 10CC and OSTEOVATION, 10CC, IMPACT FORMULA, Product Number: 390-2110, UDI: 813845020092 -… Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall OSTEOVATION RMX 10CC Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall OSTEOVATION RMX 5CC Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall OSTEOVATION, 10CC, INJECT FORMULA Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall OSTEOVATION, 3CC, IMPACT FORMULA Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall OSTEOVATION, 5CC, IMPACT FORMULA Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall OSTEOVATION, 5CC, INJECT FORMULA Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall OSTEOVATIONEX 2CC INJECT FORMULA Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall OSTEOVATIONEX 5CC, INJECT FORMULA Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall OSTEOVATIONEX, INJECT 3CC Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall SK SKAFFOLD IMPRESS 10CC Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall SKAFFOLD CMF IMPRESS (MP), 10CC Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall SKAFFOLD CMF IMPRESS (MP), 5CC Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall SKAFFOLD FLOW, 3CC and SKAFFOLD FLOW (MX) 3CC Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall SKAFFOLD FLOW (MX) 5CC Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall SKAFFOLD FLOW, 10CC Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall SKAFFOLD RENU FLOW, 10CC Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall SKAFFOLD RENU FLOW, 5CC Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall CRANIOSCULPT FLOW, CAN, 10CC, Product Number: C-FLOW10CC-CAN, UDI: 813845020375 - Product Usage: Callos is… Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall CRANIOSCULPT, CMF IMPACT, 3CC Product Number: C-CMF3CC, UDI: 813845020931 - Product Usage: Callos is… Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall CRANIOSCULPT, CMF IMPACT, 5CC, Product Number: C-CMF5CC, UDI: 813845020948 - Product Usage: Callos is… Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall CRANIOSCULPT, CMF IMPACT, 10CC, Product Number: C-CMF10CC, UDI: 813845020955 - Product Usage: Callos is… Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall EXACTECH OSSILIX MP FIL, 10CC Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall DRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to… The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, New Hampshire and New York named
- Medical device recall DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - Product Usage: intended to… The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, New Hampshire and New York named
- Medical device recall DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to… The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, New Hampshire and New York named
- Medical device recall GlideScope Core OneTouch Smart Cable When video laryngoscopy system users apply, twisting motions while connecting the blade in the HDMI port, or excessive torsion to the connection port, this… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2020ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 60 cm x 2.7 mm Lack of assurance of sterility Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 85 cm x 4.0 mm 58124 40US Lack of assurance of sterility Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)-… Lack of assurance of sterility Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)-… Lack of assurance of sterility Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling- COMBICATH 35 cm x 1.9… Lack of assurance of sterility Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling-“ COMBICATH PE 35 cm Lack of assurance of sterility Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Blood gases (PCO2, PO2) and blood pH test system Potential risk of patient mix-up on analyzers due to software issues. Class IIFDA’s classJul 15, 2020in FDA’s Enforcement Report46 statesnamed in where it went PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Blood gases (PCO2, PO2) and blood pH test system Potential risk of patient mix-up on analyzers due to software issues. Class IIFDA’s classJul 15, 2020in FDA’s Enforcement Report46 statesnamed in where it went PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Extra corporeal circuit with bio-active surface. Affected products failed a sterilization test. Class IIFDA’s classJul 15, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereCalifornia and Michigan
- Medical device recall TOMTEC-ARENA TTA2;software version no. 2.20 and lower The firm discovered a software issue associated with the Image-Com module/clinical application package (CAP) interface for 3D application in the ARENA… Class IIFDA’s classJul 15, 2020in FDA’s Enforcement Report15 statesnamed in where it went PublishedJul 15, 2020ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Connecticut, Illinois, Massachusetts, Michigan, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Texas and Virginia
- Medical device recall DABRA Laser (RA-308 Excimer Laser) A software issue was identified which could result in user or patient injury, or may adversely impact laser performance. Class IIFDA’s classJul 15, 2020in FDA’s Enforcement Report22 statesnamed in where it went PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, North Carolina, Nevada, New York, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas and Wisconsin
- Medical device recall COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Mislabeled: Printing on the top web or Tyvek lid of the individual product blister tray indicating that it contains a Pipet Current or Part Number MX140 and… Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PORT-A-CATH¿ II POWER P.A.C Smiths Medical became aware that one (1) lot of PORT-A-CATH¿ II POWER P.A.C. Class IIFDA’s classJul 15, 2020in FDA’s Enforcement Report5 statesnamed in where it went PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereArkansas, Connecticut, Mississippi, Tennessee and Texas
- Medical device recall Irix-C Forceps Inserter The strike plate fractured off from the forceps inserter devices with minimal impaction or force due to unsatisfactory weld. Class IIFDA’s classJul 15, 2020in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereArizona, Texas and West Virginia
- Medical device recall CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H7mm, Part #018.1307. Reports received of the device fracturing during insertion. Class IIFDA’s classJul 15, 2020in FDA’s Enforcement Report9 statesnamed in where it went PublishedJul 15, 2020ClassClass IIStatusCompletedWhereArizona, Florida, Indiana, Kansas, Massachusetts, Michigan, New York, Tennessee and Texas
- Medical device recall CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907. Reports received of the device fracturing during insertion. Class IIFDA’s classJul 15, 2020in FDA’s Enforcement Report9 statesnamed in where it went PublishedJul 15, 2020ClassClass IIStatusCompletedWhereArizona, Florida, Indiana, Kansas, Massachusetts, Michigan, New York, Tennessee and Texas
- Medical device recall CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308. Reports received of the device fracturing during insertion. Class IIFDA’s classJul 15, 2020in FDA’s Enforcement Report9 statesnamed in where it went PublishedJul 15, 2020ClassClass IIStatusCompletedWhereArizona, Florida, Indiana, Kansas, Massachusetts, Michigan, New York, Tennessee and Texas
- Medical device recall CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908. Reports received of the device fracturing during insertion. Class IIFDA’s classJul 15, 2020in FDA’s Enforcement Report9 statesnamed in where it went PublishedJul 15, 2020ClassClass IIStatusCompletedWhereArizona, Florida, Indiana, Kansas, Massachusetts, Michigan, New York, Tennessee and Texas
- Medical device recall CareLink SmartSync Device Manager There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of… Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 15, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Patient Connector There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of… Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 15, 2020ClassClass IIStatusOngoingWhereNo 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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