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:…
Anesthesia Machine Correction: Draeger, Inc., Issues Correction for Atlan A350 and A350 XL Anesthesia Workstations Due to Possible Mechanical Ventilation Failure
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: Atlan A350 and Atlan…
Ventilator Correction: Philips Updates Use Instructions for Trilogy Evo, EvoO2, EV300, Evo Universal, Aeris EVO, Garbin Evo, and LifeVent EVO2 due to Risk of Inaccurate Flow Measurements Caused By Certain In-Line Nebulizer Placements
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 Products Product Names:…
Mxbbb Issues Voluntary Nationwide Recall of Umary Acid Hyaluronic Due to the Presence of Diclofenac and Omeprazole
Summary Company Announcement Date: November 19, 2024 FDA Publish Date: November 20, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description The product contains undeclared diclofenac and omeprazole Company Name: MXBBB Brand Name: Brand Name(s) Product Description: Product Description UMARY Hyaluronic Acid tablets Company Announcement MXBBB is voluntarily recalling 1 lot of UMARY ACID…
Endo Expands Voluntary Recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) Due to Potential Product Carton Strength Mislabeling
Summary Company Announcement Date: November 18, 2024 FDA Publish Date: November 19, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Mislabeled with the incorrect strength on the carton Company Name: Endo, Inc. Brand Name: Brand Name(s) Par Pharmaceutical Product Description: Product Description Clonazepam Orally Disintegrating Tablets, USP (C-IV) Company Announcement Endo, Inc. (OTCQX:…
Endoscopic Vessel Harvesting System Recall: Getinge and Maquet Cardiovascular Remove VasoView HemoPro 1 and 1.5 Endoscopic Vessel
The devices described in this recall are included in the related Letter to Health Care Providers. On November 15, 2024, the FDA added EVH devices (product code GEI) to the medical device shortage list. See the related Letter to Health Care Providers for the most current information on these devices. This recall involves removing certain…
Safety and Availability Concerns with VasoView HemoPro Endoscopic Vessel Harvesting Systems – Letter to Health Care Providers
November 15, 2024 The U.S. Food and Drug Administration (FDA) is alerting health care providers and facilities about safety concerns with the use of Getinge/Maquet VasoView HemoPro Endoscopic Vessel Harvesting (EVH) Systems, and a supply concern for EVH devices. On September 20, 2024, Getinge/Maquet issued an Urgent Medical Device Removal notice to inform users to…
VitalityVita Issues Voluntary Nationwide Recall of VitalityXtra and PeakMax Capsules Due to the Presence of Undeclared Sildenafil and Diclofenac
Summary Company Announcement Date: November 04, 2024 FDA Publish Date: November 06, 2024 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Undeclared Sildenafil and Diclofenac Company Name: VitalityVita Brand Name: Brand Name(s) VitalityVita Product Description: Product Description Marketed as Dietary Supplement Company Announcement FOR IMMEDIATE RELEASE – 11/04/24 – Sacramento, CA, VitalityVita.com is…
Boulla LLC Issues Voluntary Nationwide Recall of ZoomMax and ZapMax Capsules Due to the Presence of Undeclared Sildenafil and Diclofenac
Summary Company Announcement Date: November 04, 2024 FDA Publish Date: November 05, 2024 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Undeclared Sildenafil and Diclofenac Company Name: Boulla LLC Brand Name: Brand Name(s) Boulla LLC Product Description: Product Description Marketed as Dietary Supplement Company Announcement FOR IMMEDIATE RELEASE – 11/04/24 – Sacramento, CA,…
IPV Therapy Device Recall: Percussionaire Removes Certain Phasitron 5 Breathing Circuits Due to Risk of Nickel Exposure
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: Phasitron 5 breathing circuits Part Numbers/Lot Numbers: P5-10/240329, 240412,240430, 240509, 240516, 240614, 240625 …