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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 06/10/2022Medtronic 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 Material06/03/2022FAQs on Philips
Respironics Ventilator, BiPAP Machine, and CPAP Machine RecallsMedical
Devices06/03/2022Philips Respironics Recalls All V60 and V60 Plus Ventilators
for Power Issue that May Cause Ventilator to Stop with or without Alarms

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