November 17, 2022, Update: The FDA took an additional action related to the need for repeat testing following a negative COVID-19 test result on COVID-19 antigen tests — revising the emergency use authorizations (EUAs) of all authorized COVID-19 antigen tests on November 1, 2022. For details, see FDA Actions below. Date Issued: August 11, 2022…
Insulet Recalls Omnipod DASH Insulin Management System’s Personal Diabetes Manager (PDM) for Risk of Battery Swelling, Leakage, or Extreme Overheating
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Name: Insulet Omnipod DASH Insulin Management System Personal Diabetes Manager (PDM) Product Models: 18239 ASM Omnipod DASH PDM PT-000010: Assembly, DASH Final PDM U100, mg/dL PT-000011:…
How to Buy Medicines Safely From an Online Pharmacy
Image Español Have you ever been tempted to buy your medicines from an online pharmacy or another website? You can protect yourself and your family by being cautious when buying medicine online. Some pharmacy websites operate legally and offer convenience, privacy, cost savings and safeguards for purchasing medicines. Not all websites are the same. The…
Insulet Issues a Nationwide Voluntary Medical Device Correction for the Omnipod® 5 Controller
Summary Company Announcement Date: November 14, 2022 FDA Publish Date: November 15, 2022 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Issue with the Omnipod 5 Controller charging port and cable Company Name: Insulet Corporation Brand Name: Brand Name(s) Insulet Corporation Omnipod Product Description: Product Description Automated Insulin Delivery System Company Announcement ACTON,…
Whele LLC Announces National Voluntary Recall of Mighty Bliss Electric Heating Pad Due to Product Safety Concerns
Summary Company Announcement Date: October 24, 2022 FDA Publish Date: October 24, 2022 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Use of product may lead to burns, mild shocks, or rashes and irritation Company Name: Whele LLC Brand Name: Brand Name(s) Mighty Bliss Product Description: Product Description Heating pads Company Announcement Boston,…
Do Not Use Certain Mighty Bliss Electric Heating Pads Due to Risk of Injury: FDA Safety Communication
Date Issued: October 25, 2022 The U.S. Food and Drug Administration (FDA) is warning consumers, caregivers and health care providers not to use the recalled Mighty Bliss electric heating pads distributed by Whele LLC (doing business as Perch) due to the risks of injury, including electric shocks, skin burns, rashes or irritation. On October 24,…
Mylan Institutional LLC, a Viatris Company, Issues a Voluntary Recall of One Lot of Octreotide Acetate Injection, 500 mcg/mL, Due to Glass Particulates in a Syringe
Summary Company Announcement Date: October 25, 2022 FDA Publish Date: October 25, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to glass particulates Company Name: Mylan Institutional LLC, a Viatris company Brand Name: Brand Name(s) Mylan Institutional LLC Product Description: Product Description Octreotide Acetate Injection, 500 mcg/mL Company Announcement FOR IMMEDIATE RELEASE…
Reuse Tracheostomy Tubes or Switch to Appropriate Alternatives During Shortage: FDA Safety Communication
Date Issued: October 31, 2022 The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers that there is a shortage of tracheostomy tubes, including Bivona tracheostomy tubes manufactured by ICU Medical. A shortage of Bivona tracheostomy tubes is more likely to impact pediatric patients because the supply of alternative tubes…
Consider Alternatives for MRI-Guided Breast Biopsy Grid Plates Due to Shortage – Letter to Health Care Providers
October 31, 2022 The U.S. Food and Drug Administration (FDA) is recommending health care providers discuss alternative options for Magnetic Resonance Imaging (MRI)-guided breast biopsy procedures with patients if a facility is unable to perform the biopsy due to a shortage of Philips Invivo MRI breast biopsy grid plates and other Philips Invivo MRI disposables. …
Should Your Child Participate in a Clinical Trial?
Image Español Clinical trials help provide reliable evidence needed when studying medical products to diagnose, prevent, treat, and sometimes even cure, childhood diseases. Children who participate in these research studies may also potentially benefit from the medical products under investigation. Before deciding whether your child should participate in a clinical trial, there’s a lot to…