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,…
Boston Baking Issues Allergy Alert on Undeclared Pecans in “Boston Baking Mini Cinnamon Crumb Cakes”
Summary Company Announcement Date: November 14, 2022 FDA Publish Date: November 14, 2022 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared pecans Company Name: Boston Baking, Inc. Brand Name: Brand Name(s) Boston Baking Product Description: Product Description Mini Cinnamon Crumb Cake Company Announcement BOSTON BAKING, Inc. of Boston, MA, is recalling…
Big Sky Bread Company Issues Allergy Alert on Undeclared Milk in Chocolate Chunk Granola and Chocolate Chunk Peanut Butter Chip Granola
Summary Company Announcement Date: November 09, 2022 FDA Publish Date: November 14, 2022 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared milk Company Name: Big Sky Bread Company Brand Name: Brand Name(s) Big Sky Bread Company Product Description: Product Description Chocolate Chunk Granola and Chocolate Chunk Peanut Butter Chip Granola Company…
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…
Seven Seas International USA, LLC Voluntarily Recalls Giant Food Private Label Wild Caught Alaskan Sockeye Smoked Salmon Because of Possible Health Risk
Summary Company Announcement Date: November 08, 2022 FDA Publish Date: November 08, 2022 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential Listeria monocytogenes contamination Company Name: Seven Seas International USA, LLC Brand Name: Brand Name(s) Product Description: Product Description Smoked Salmon Company Announcement Product Name: Giant Private Label Wild Caught Alaskan…