Effective Medicine

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:…