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…
Early Alert: WATCHMAN Access System Issue from Boston Scientific
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…
FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live): FDA Safety Communication
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…
Early Alert: Electrophysiology Catheter Issue from Medline ReNewal
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…
Early Alert: Defibrillation Lead Issue from Boston Scientific
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…
FDA is Requiring Opioid Pain Medicine Manufacturers to Update Prescribing Information Regarding Long-Term Use: Drug Safety Communication
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…
Continuous Ventilator Correction: Philips Respironics Updates Use Instructions for BiPAP A30, A40, and V30 Devices Due to Interruptions and/or Loss of Therapy
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…
Products Containing 7-OH Can Cause Serious Harm
Image Products Containing 7-OH Can Cause Serious Harm Tempted to try products containing 7-hydroxymitragynine (also known as 7-OH) – such as tablets, gummies, drink mixes, and shots – sold online and at smoke shops and gas stations? Consider this: 7-OH products are novel potent opioid products that have not been proven safe or effective for…
Cranial Drill Recall: Integra LifeSciences Recalls Codman Disposable Perforators Due to Risk of Device Disassembly
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…
Continuous Ventilator (Respirator) Correction: Maquet Critical Care AB Updates Use Instructions for Servo Ventilator Systems Due to Risk of Inaccurate Compliance Measurement Leading to Improper Tidal Volume Delivery in Neonatal Patients
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:…