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,…

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,…

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…

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…

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. …

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…

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…

Summary Company Announcement Date: November 05, 2022 FDA Publish Date: November 07, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of methanol Company Name: Adam’s Polishes, LLC Brand Name: Brand Name(s) Adam’s Polishes Product Description: Product Description Hand sanitizer Company Announcement FOR IMMEDIATE RELEASE November 10th, 2022 – Thornton, Colorado, Adam’s Polishes,…

Summary Company Announcement Date: November 03, 2022 FDA Publish Date: November 04, 2022 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Filter may split or detach during use Company Name: Teleflex Incorporated Brand Name: Brand Name(s) Gibeck® and Iso-Gard® Product Description: Product Description Bacterial and viral filters Company Announcement WAYNE, Pa., Nov. 03,…

Summary Company Announcement Date: November 04, 2022 FDA Publish Date: November 05, 2022 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Battery issue: battery swelling, leakage, and in rare cases, extreme overheating, which has resulted in reports of fire. Company Name: Insulet Corporation Brand Name: Brand Name(s) Insulet Corporation Omnipod DASH Product Description:…