This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. 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…
Continuous Glucose Monitor Apps Correction: Dexcom, Inc. Issues Correction for G7 Apps and ONE+ Apps due to a Software Design Error That Does Not Alert Users of Unexpected Sensor Failure
This recall involves correcting certain devices through a software update 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:…
Ventilator Recall: Philips Respironics Removes Certain DreamStation Devices Due to Programming Errors That Can Result in Failed Therapy Modes
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 Description Model Number UDI-DI DreamStation Auto CPAP UDSX500S11F 00606959423314 DreamStation Auto BiPAP UDSX700S11F 00606959423338…
DermaRite Industries Expands Voluntary Nationwide Recall Due to Potential Burkholderia cepacia Contamination
Summary Company Announcement Date: August 27, 2025 FDA Publish Date: August 28, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety – Potential Burkholderia cepacian contamination Company Name: DermaRite Industries Brand Name: Brand Name(s) Product Description: Product Description Hand Sanitizers, Cleansers, Skin Protectants, Deodorant Company Announcement DermaRite Industries, LLC is…
Ventilator Correction: Hamilton Medical AG Corrects HAMILTON-C6 Due to Risk of Ventilation Interruption from Defective Circuit Board
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 Names: HAMILTON-C6 ventilator Unique Device Identifier (UDI)/Model: UDI: 76300028PN160021ZW Model: 160021 Lot/Serial Numbers: 13636–13950…
Applicator Recall: Integra LifeSciences Removes Extended Tip Applicator Due to Potential Sterility and Endotoxin Concerns
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…