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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:

 * Prescription and over-the-counter medicines
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   therapies.
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Product Type Biologics Drugs Medical Devices
Year 202220212020201920182017
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DateSafety AlertProduct Type 11/07/2022Adam’s Polishes, LLC Issues Voluntary
Nationwide Recall of Hand Sanitizer Due to Potential Contamination With
MethanolDrugs, Impurity11/07/2022Pulse Oximeter Accuracy and Limitations: FDA
Safety CommunicationMedical Devices11/05/2022Insulet Issued Voluntary Medical
Device Correction for Omnipod DASH® Personal Diabetes Manager on October 17,
2022Defect, Medical Devices11/04/2022Teleflex Announces Worldwide Recall of
Gibeck® Iso-Gard® FilterDefect, Medical Devices11/03/20222022 Safety
CommunicationsMedical Devices, Radiation-Emitting Products11/03/2022Do Not Use
Infant Head Shaping Pillows to Prevent or Treat Any Medical Condition: FDA
Safety CommunicationMedical Devices11/02/2022Teleflex Recalls Iso-Gard Filter S
for Risk of Splitting or Detaching That May Cause Leakage and Insufficient Air
Supply to PatientsMedical Devices11/01/20222022 Letters to Health Care
ProvidersMedical Devices, Radiation-Emitting Products11/01/20222022 Medical
Device RecallsMedical Devices, Radiation-Emitting Products10/31/2022Consider
Alternatives for MRI-Guided Breast Biopsy Grid Plates Due to Shortage - Letter
to Health Care ProvidersMedical Devices

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