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 1. Safety


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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 * Food such as beverages and ingredients added to foods.

Other products that the FDA regulates include tobacco products, vaccines, and
animal drugs, devices and food, including pet food. These products utilize
different reporting pathways and it is recommended that reports concerning these
products be submitted directly to the appropriate portals.




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Product Type Biologics Drugs Medical Devices
Year 202220212020201920182017
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DateSafety AlertProduct Type 06/23/20222022 Medical Device RecallsMedical
Devices, Radiation-Emitting Products06/23/2022Baxter Healthcare Corporation
Recalls Volara System For Risk Of Respiratory Distress In Ventilated Patients
During Home UseMedical Devices06/23/2022Medtronic Recalls HeartWare HVAD System
Batteries Due to Battery FailureMedical Devices06/22/2022BD Announces Voluntary
Recall on Intraosseous ProductsDefect, Medical Devices06/22/2022Vi-Jon, LLC
Issues Voluntary Nationwide Recall of CVS Magnesium Citrate Saline Laxative Oral
Solution Lemon Flavor Due to Microbial ContaminationDrugs, Microbial
Contamination06/21/2022Draeger, Inc Recalls SafeStar 55 Breathing System Filters
for Possible Obstructions That May Block Oxygen Flow To PatientsMedical
Devices06/21/2022Pulse Oximeter Accuracy and Limitations: FDA Safety
CommunicationMedical Devices06/21/2022Use Duodenoscopes with Innovative Designs
to Enhance Safety: FDA Safety CommunicationMedical Devices06/21/2022UPDATE on
Type III Endoleaks Associated with Endovascular Graft Systems – Letter to Health
Care Providers06/14/2022Latin 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 Ingredient

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