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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.

   Report a Problem
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   Stay Informed

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.
 * Combination products such as pre-filled drug syringe, metered-dose inhalers
   and nasal spray.
 * Special nutritional products such as dietary supplements, medical foods and
   infant formulas.
 * Cosmetics such as moisturizers, makeup, shampoos, hair dyes and tattoos.
 * Food such as beverages and ingredients added to foods.

Other products that the FDA regulates include tobacco products, vaccines, and
animal drug, device, pet food and livestock feed. 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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DateSafety AlertProduct Type 11/23/20222022 Medical Device RecallsMedical
Devices, Radiation-Emitting Products11/23/2022Baxter Hillrom Recalls WatchCare
Incontinence Management System (IMS) for Risk of RF Interference with Nearby
Medical Equipment Medical Devices11/22/2022FAQs on Philips Respironics
Ventilator, BiPAP Machine, and CPAP Machine RecallsMedical
Devices11/22/2022Update: Certain Philips Respironics Ventilators, BiPAP
Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety
CommunicationMedical Devices11/22/2022Prolia (denosumab) by Amgen: Drug Safety
Communication - FDA Investigating Risk of Severe Hypocalcemia in Patients on
Dialysis Drugs11/18/20222022 Safety CommunicationsMedical Devices,
Radiation-Emitting Products11/17/2022At-Home COVID-19 Antigen Tests-Take Steps
to Reduce Your Risk of False Negative Results: FDA Safety CommunicationMedical
Devices11/16/2022Insulet Recalls Omnipod DASH Insulin Management System's
Personal Diabetes Manager (PDM) for Risk of Battery Swelling, Leakage, or
Extreme OverheatingMedical Devices11/15/2022Insulet Issues a Nationwide
Voluntary Medical Device Correction for the Omnipod® 5 ControllerDefect, Medical
Devices11/07/2022Adam’s Polishes, LLC Issues Voluntary Nationwide Recall of Hand
Sanitizer Due to Potential Contamination With MethanolDrugs, Impurity

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