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 Catalog Number Product Name (Description) UDI-DI Lots Affected 205108 Extended Tip Applicator, 8CM, Box of…
Mobile Power Unit AC Power Cord Recall: Abbott Medical Removes AC Power Cord Associated with HeartMate Mobile Power Unit (MPU) Due to Potential Risk of the Cord Not Locking into Place
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: AC Power Cord (model: 107760) for the HeartMate Mobile Power Unit (model: 107754)…
Breathing Circuit Set Recall: Hamilton Medical, Inc. Removes Coaxial Breathing Circuit Set Due to Possible Inner Blue Tube Cracks That May Impact Ventilation
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 Part number Lot numbers Breathing circuit set, coaxial 260128 199675 Breathing circuit set,…
Green Lumber Holding, LLC Issues Consumer Alert on Counterfeit Products Following FDA Findings
Summary Company Announcement Date: August 28, 2025 FDA Publish Date: August 29, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared prescription drug-Tadalafil Company Name: Green Lumber Holding, LLC. Brand Name: Brand Name(s) Green Lumber Product Description: Product Description Dietary Supplement Company Announcement Costa Mesa, California August 28, 2025 – Green Lumber Holding,…
Manual Resuscitator Recall: Ambu Inc. Removes SPUR II Resuscitators Due to Blocked Manometer Port
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 What to Do Do not use Ambu SPUR II resuscitators from affected lots. Identify…
Infusion Pump Correction: ICU Medical, Inc. Issues Correction for Plum Duo Infusion System Due to Software Possibly Resulting in Pump Becoming Unresponsive
This recall involves correcting certain 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 Names: Plum Duo Infusion System…
Unichem Pharmaceuticals (USA) Inc. Issues Voluntary Nationwide Recall of Cyclobenzaprine Hydrochloride Tablets USP 10 mg, Due to Mislabeling
Summary Company Announcement Date: August 27, 2025 FDA Publish Date: August 27, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety – Mislabel Company Name: Unichem Pharmaceuticals Brand Name: Brand Name(s) Unichem Pharmaceuticals Product Description: Product Description Cyclobenzaprine Hydrochloride Tablets USP 10 mg Company Announcement FOR IMMEDIATE RELEASE – 08/27/2025–…
FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live). FDA Suspends Biologics License: FDA Safety Communication
AUDIENCE: Patient, Health Care Professional, Pharmacy, Cardiology, Neurology, Internal Medicine, Family Practice, Travel Clinics UPDATE: On August 22, 2025, the US FDA’s Center for Biologics Evaluation and Research (CBER) has suspended the biologics license for Valneva Austria GmbH’s Ixchiq (Chikungunya Vaccine, Live). This vaccine was initially approved by FDA under the accelerated approval pathway in…
Follow Instructions for Safe Use of Hyperbaric Oxygen Therapy Devices – Letter to Health Care Providers
August 25, 2025 The U.S. Food and Drug Administration (FDA) is reminding health care providers and facilities about the safe use of hyperbaric oxygen therapy (HBOT) devices and the importance of following the manufacturer’s instructions for use. The FDA is aware of reports of serious injuries and deaths with use of HBOT devices and is…
Vascular Stent Recall: Boston Scientific Removes Carotid WALLSTENT Monorail Endoprosthesis Due to Risk of Resistance During Device Withdrawal
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 Lot Number UDI-DI (GTIN) CAROTID WALLSTENT MONORAIL 10.0-24 H7493915010240 08714729781097 CAROTID WALLSTENT MONORAIL…