Summary Company Announcement Date: August 08, 2025 FDA Publish Date: August 09, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Contamination with Burkholderia cepacia Company Name: DermaRite Industries, LL Brand Name: Brand Name(s) DermaKleen, Dermasarra, Kleenfoam, and Perigiene Product Description: Product Description OTC antiseptic lotion soaps, external analgesics, antimicrobial foam soaps, and antiseptic…

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product The FDA is aware that Boston Scientific has issued…

AUDIENCE: Patient, Health Care Professional, Pharmacy, Cardiology, Neurology, Internal Medicine, Family Practice, Travel Clinics ISSUE: On May 9, 2025, FDA issued a safety communication informing the public that the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) jointly recommended a pause in the use of Ixchiq (Chikungunya Vaccine, Live) in individuals…

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product The FDA is aware that Medline ReNewal has issued…

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product The FDA is aware that Boston Scientific has issued…

AUDIENCE: Patient, Health Care Professional, Pain Management ISSUE: In May 2025, the FDA convened a joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee to discuss two recently completed observational studies examining the risks of misuse, abuse, addiction, and fatal and non-fatal overdose in…

This recall involves correcting devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction. Affected Product Product Name UDI / Model Number Lot/Serial Numbers…

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product Product Name Unique Device Identifier (UDI) Codman Disposable Perforator 14 mm 10381780513599 Codman Craniotomy Kit…

This recall involves updating instructions for using devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions. Affected Product Product Names:…

Craniotomy Kit DYNJ35349C 10888277858060 (EA), 40888277858061 (CASE) 24CBJ925, 24DBT405, 24FBO318 CRANI Accessory Pack DYNJ59270 10888277771512 (EA), 40888277771513 (CASE) 23JDB683, 23JDC548, 24ADB783, 24HDA822 CRANI PACK-LF DYNJ44805M 10195327506872 (EA), 40195327506873 (CASE) 23JBI747, 23KBL228, 24ABG696, 24CBM117, 24EBQ114, 24GBJ699 CRANIOTOMY KIT CDS982719V 10195327510831 (EA), 40195327510832 (CASE) 23KBP461, 23LBN381, 24ABB119, 24BBC547, 24BBI145 CRANIOTOMY KIT CDS982719W 10195327645090 (EA), 40195327645091 (CASE) 24DBS813…