Medical devices, 2023
Shortlist up to four to read them side by side.
2,477 medical device recalls FDA’s Enforcement Report published in 2023, 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.
2,477of 2,477 medical device recallsshown with your filters
The list
- Medical device recall smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW The firm conducting a recall due to a complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 4N LT implant instead of a LEGION… Class IIFDA’s classSep 27, 2023in FDA’s Enforcement Report7 statesnamed in where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereCalifornia, Connecticut, North Carolina, Nebraska, Nevada, Ohio and Texas
- Medical device recall COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing… Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults. Class IIFDA’s classSep 27, 2023in FDA’s Enforcement Report16 statesnamed in where it went PublishedSep 27, 2023ClassClass IIStatusCompletedWhereArizona, California, Georgia, Iowa, Indiana, Kansas, Louisiana, Minnesota, North Carolina, New Mexico, New York, Ohio, Oregon, Texas, Virginia and Vermont
- Medical device recall VITROS XT Chemistry Products TBIL-ALKP Slides Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not… Class IIFDA’s classSep 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITROS XT Chemistry Products ALKP Slides Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not… Class IIFDA’s classSep 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Tempus Pro Patient Monitor Full screen error message may occur on patient monitors with affected hardware version, either during or after laryngoscopes are unplugged from monitors,… Class IIFDA’s classSep 27, 2023in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small One respirator sample failed a filtration efficiency test. Class IIFDA’s classSep 27, 2023in FDA’s Enforcement Report11 statesnamed in where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereFlorida, Georgia, Iowa, Illinois, Missouri, Mississippi, Nebraska, Oklahoma, Tennessee, Texas and Wisconsin
- Medical device recall Perifix¿ / Epidural anesthesia set, medicated Product may be mislabeled with an incorrect lid stock label. Class IIFDA’s classSep 27, 2023in FDA’s Enforcement Report13 statesnamed in where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereArkansas, Arizona, California, Florida, Georgia, Illinois, Massachusetts, Missouri, North Carolina, New Jersey, Pennsylvania, Texas and Washington
- Medical device recall Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IStatusOngoingWhereNo state named
- Medical device recall Proclaim XR 5 Implantable Pulse Genterator Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedSep 20, 2023ClassClass IStatusOngoingWhereNationwide, and Alaska, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Proclaim” XR 7 Implantable Pulse Generator Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedSep 20, 2023ClassClass IStatusOngoingWhereNationwide, and Alaska, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Proclaim Plus 5 Implantable Pulse Generator Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedSep 20, 2023ClassClass IStatusOngoingWhereNationwide, and Alaska, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Proclaim Plus 7 Implantable Pulse Generator Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedSep 20, 2023ClassClass IStatusOngoingWhereNationwide, and Alaska, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Proclaim DRG Implantable Pulse Generator Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedSep 20, 2023ClassClass IStatusOngoingWhereNationwide, and Alaska, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Infinity 5 Implantable Pulse Generator Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedSep 20, 2023ClassClass IStatusOngoingWhereNationwide, and Alaska, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Infinity 7 Implantable Pulse Generator Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedSep 20, 2023ClassClass IStatusOngoingWhereNationwide, and Alaska, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 20, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Magnifuse Bone Graft, Large, Size: 14mm x 25mm The incorrect product labeling was applied to the product indicating the wrong size of product. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedSep 20, 2023ClassClass IIStatusOngoingWhereNationwide, and Idaho, Indiana, Minnesota, North Carolina, New York, Ohio, Oregon, Washington and Wisconsin named
- Medical device recall remel TODD HEWITT W On lot of Todd Hewitt Broth w/CNA (LIM) may exhibit no recovery of target organism during customer QC testing or use with patient samples Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 20, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ASG-001; Ultrasound gel Ultrasound gel mislabeled with inappropriate use. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall 50-GEL20; Ultrasound gel Ultrasound gel mislabeled with inappropriate use. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Procedural kits containing ultrasonic transmission gel Ultrasound gel mislabeled with inappropriate use. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Procedural kits containing ultrasonic transmission gel Ultrasound gel mislabeled with inappropriate use. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Procedural kits containing ultrasonic transmission gel Ultrasound gel mislabeled with inappropriate use. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall procedural kits containing ultrasonic transmission gel Ultrasound gel mislabeled with inappropriate use. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall nanoDot D2DNS, for custom calibrate, OTO LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusCompletedWhereNo state named
- Medical device recall nanoDot D2DNS, for custom calibrate, OTO LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusCompletedWhereNo state named
- Medical device recall nanoDot D2DNN LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusCompletedWhereNo state named
- Medical device recall nanoDot D2DNN LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusCompletedWhereNo state named
- Medical device recall nanoDot D2DNS LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusCompletedWhereNo state named
- Medical device recall nanoDot D2DNS LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusCompletedWhereNo state named
- Medical device recall nanoDot D2DNS LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusCompletedWhereNo state named
- Medical device recall nanoDot D2DXN LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusCompletedWhereNo state named
- Medical device recall nanoDot D2DXN LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusCompletedWhereNo state named
- Medical device recall nanoDot D2DXS LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusCompletedWhereNo state named
- Medical device recall nanoDot D2DXS LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusCompletedWhereNo state named
- Medical device recall Calibrate (80 kVp) screened nanoDot D2DNS, Model Number 03064-OTO; radiation monitoring dosimeter used with… LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusCompletedWhereNo state named
- Medical device recall Calibrate (Cs-137) screened nanoDot D2DNS LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusCompletedWhereNo state named
- Medical device recall QC (80 kVp) screened nanoDot D2DNS, Model Number 03066-OTO; radiation monitoring dosimeter used with the… LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusCompletedWhereNo state named
- Medical device recall QC (Cs-137) screened nanoDot D2DNS LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusCompletedWhereNo state named
- Medical device recall nanoDot kit (contains nanoDot A, B, C) LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusCompletedWhereNo state named
- Medical device recall nanoDot A - item 1 of 3 for 03500-000 LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusCompletedWhereNo state named
- Medical device recall nanoDot B - item 2 of 3 for 03500-000 LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusCompletedWhereNo state named
- Medical device recall nanoDot C - item 3 of 3 for 03500-000 LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusCompletedWhereNo state named
- Medical device recall Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 04217-000 (EMEA number VINLNAN003); b) 04217-KIT; c)… LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusCompletedWhereNo state named
- Medical device recall QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 04218-000 (EMEA number VINLNAN004); b) 04218-KIT; c) 04218-SET;… LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusCompletedWhereNo state named
- Medical device recall Calibrate (Cs-137) nanoDot D2DNS LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusCompletedWhereNo state named
- Medical device recall QC (Cs-137) nanoDot D2DNS LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusCompletedWhereNo state named
- Medical device recall nanoDot D2DNN LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusCompletedWhereNo 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.
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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