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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
professionals, patients and consumers.

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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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Other products that the FDA regulates include tobacco products, vaccines, and
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Product Type Biologics Drugs Medical Devices
Year 202220212020201920182017
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DateSafety AlertProduct Type 08/31/20222022 Medical Device RecallsMedical
Devices, Radiation-Emitting Products08/30/2022Intera Oncology Recalls Intera
3000 Hepatic Artery Infusion Pump Due to Faster Than Expected Flow Rates That
May Impact Infusion DeliveryMedical Devices08/29/20222022 Safety
CommunicationsMedical Devices, Radiation-Emitting Products08/29/2022Certain
Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue: FDA Safety
CommunicationMedical Devices08/29/2022Hamilton Medical AG Recalls Hamilton-C6
Intensive Care Ventilator Due to Potential Water Ingress that May Cause
Breathing Support to StopMedical Devices08/26/2022Update: FDA No Longer
Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators -
Letter to Health Care Personnel and FacilitiesMedical Devices08/25/2022Medtronic
Recalls HeartWare HVAD System Batteries for Electrical Faults That Cause Battery
FailureMedical Devices08/22/2022Hospira Issues A Voluntary Nationwide Recall For
One Lot of Propofol Injectable Emulsion (Containing Benzyl Alcohol), Due To The
Potential Presence of Visible ParticulatesDrugs, Potential Foreign
Material08/19/2022Medtronic Recalls Cobalt XT, Cobalt and Crome ICDs and CRT-Ds
for Risk that Devices May Issue a Short Circuit Alert and Deliver Reduced Energy
Shock During High Voltage TherapyMedical Devices08/18/20222022 Letters to Health
Care ProvidersMedical Devices, Radiation-Emitting Products

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