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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:

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   therapies.
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Product Type Biologics Drugs Medical Devices
Year 202220212020201920182017
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DateSafety AlertProduct Type 06/03/20222022 Medical Device RecallsMedical
Devices, Radiation-Emitting Products06/03/2022FAQs 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
Alarms06/02/20222022 Safety CommunicationsMedical Devices, Radiation-Emitting
Products06/02/2022Atrium Medical Corporation Recalls iCast Covered Stent for
Potential Balloon or Catheter Hub Separation That May Cause Patient HarmMedical
Devices06/02/2022Baxter Issues Urgent Medical Device Correction to Reinforce
Important Safety Information Regarding Possible Risk of Oxygen Desaturation
While Using Volara Device in Line With Ventilator in a Home Care
EnvironmentDefect, Medical Devices06/02/2022FDA Warns Against Use of
Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety
CommunicationMedical Devices06/02/2022Illumina Cybersecurity Vulnerability May
Present Risks for Patient Results and Customer Networks: Letter to Health Care
ProvidersMedical Devices06/02/2022UPDATE: FDA Updates Recommendations for the
Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety
Communication Medical Devices06/01/2022Ukoniq (umbralisib): Drug Safety
Communication - FDA Approval of Lymphoma Medicine is Withdrawn Due to Safety
ConcernsDrugs, Oncology

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