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MEDWATCH: THE FDA SAFETY INFORMATION AND ADVERSE EVENT REPORTING PROGRAM

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MedWatch, the FDA’s medical product safety reporting program for health
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MedWatch receives reports from the public and when appropriate, publishes safety
alerts for FDA-regulated products such as:

 * Prescription and over-the-counter medicines
 * Biologics such as blood components, blood/plasma derivatives and gene
   therapies.
 * Medical devices such as hearing aids breast pumps, and pacemakers.
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Product Type Biologics Drugs Medical Devices
Year 202220212020201920182017
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DateSafety AlertProduct Type 06/14/2022Latin Foods Market Issues Voluntary
Nationwide Recall of Artri King Reforzado Con Ortiga Y Omega 3 Due to the
Presence of Undeclared Diclofenac and DexamethasoneDrugs, Unapproved
Ingredient06/14/2022UPDATE: Potential Risk of Infection When Using Heater-Cooler
Devices – Letter to Health Care ProvidersMedical Devices06/10/2022Medtronic
Recalls HVAD Pump Implant Kit for Pump Weld DefectMedical
Devices06/10/2022Potential for Internal Pump Malfunction in the Medtronic HVAD
System – Letter to Health Care ProvidersMedical Devices06/09/20222022 Medical
Device RecallsMedical Devices, Radiation-Emitting Products06/09/2022Green
Pharmaceuticals Inc Issues Voluntary Nationwide Recall of SnoreStop NasoSpray
Due to Microbial ContaminationDrugs, Microbial Contamination06/09/2022Woodside
Acquisitions Inc. Recalls Oral Rapid SARS-CoV-2 Antigen Rapid Test Kits and
Joysbio SARS-CoV-2 Antigen Rapid Test Kits (Colloidal Gold) That Are Not
Authorized, Cleared, or Approved by the FDAMedical Devices06/08/2022Atrium
Medical Corporation Recalls iCast Covered Stent for Potential Balloon or
Catheter Hub Separation That May Cause Patient HarmMedical
Devices06/08/2022Plastikon Healthcare Issues Voluntary Nationwide Recall of Milk
of Magnesia Oral Suspension and Magnesium Hydroxide /Aluminum Hydroxide
/Simethicone Oral Suspension Due to Microbial ContaminationDrugs, Potential
Foreign Material06/07/2022Buzzagogo, Inc. Issues Voluntary Nationwide Recall of
Allergy Bee Gone for Kids Nasal Swab Remedy Due to Potential Microbial
ContaminationDrugs, Potential Foreign Material

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