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…
Teleflex Recalls Iso-Gard Filter S for Risk of Splitting or Detaching That May Cause Leakage and Insufficient Air Supply to Patients
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: Iso-Gard Filter S Product Models: See recall database entries Distribution Dates: September 1, 2020 to July 5, 2022 Devices Recalled in the U.S.: 60,500 Date…
Do Not Use Infant Head Shaping Pillows to Prevent or Treat Any Medical Condition: FDA Safety Communication
Date issued: 11/3/2022 The U.S. Food and Drug Administration (FDA) recommends that parents and caregivers do not use infant head shaping pillows intended to change an infant’s head shape or symmetry or claim to prevent or treat any medical condition. The FDA is not aware of any demonstrated benefit with the use of infant head…
Comercializadora PepsiCo S. de R.L. de C.V. Issues Voluntary Recall of Gamesa® Arcoiris Marshmallow Cookies Due to Possible Health Risk
Summary Company Announcement Date: November 07, 2022 FDA Publish Date: November 07, 2022 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential presence of Salmonella Company Name: Comercializadora PepsiCo S. de R.L. de C.V. Brand Name: Brand Name(s) Product Description: Product Description Arcoiris Marshmallow Cookies Company Announcement Comercializadora PepsiCo S. de R.L….