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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 05/10/20222022 Medical Device RecallsMedical
Devices, Radiation-Emitting Products05/10/20222022 Safety CommunicationsMedical
Devices, Radiation-Emitting Products05/10/2022Do Not Use Skippack Medical Lab
SARS-CoV-2 Antigen Rapid Test: FDA Safety CommunicationMedical
Devices05/10/2022SML Distribution LLC Recalls Skippack Medical Lab COVID-19
Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the
FDAMedical Devices05/09/2022 Mesa Biotech, Inc., Recalls Certain Accula
SARS-CoV-2 Tests for Risk of False Positives Caused by Contamination Medical
Devices05/06/2022Potential Risk of Exposure to Toxic Compounds When Using
Certain Hemodialysis Machines Manufactured by Fresenius Medical Care – Letter to
Health Care ProvidersMedical Devices05/02/2022Fagron Inc. Issues Voluntary
Nationwide Recall of SyrSpend SF Cherry Due to Microbial ContaminationDrugs,
Potential Foreign Material, Potential Spoilage05/02/2022Philips Respironics
CPAP, BiPAP, and Ventilator Recalls: Frequently Asked QuestionsMedical
Devices05/02/2022Philips Respironics Issues Voluntary Recall Notification/Field
Safety Notice* for the V60 Ventilator Product FamilyDefect, Medical
Devices04/28/2022Celltrion USA Recalls Certain Point of Care DiaTrust COVID-19
Ag Rapid Test Kits Which May Have Been Distributed to Unauthorized,
Non-CLIA-Certified UsersMedical Devices

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