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: microTargeting Insertion Tube Set Unique Device Identifier (UDI)/Product Model: 10873263004323/66-IT-05P Lot Number: 244517…
Hemodialysis Correction: Baxter Issues Correction for AK 98 Hemodialysis Machines Due to Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBA and/or NDL-PCBs
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 Name: AK 98 Hemodialysis Machine Unique…
Biopsy Needle Recall: Elekta Removes Disposable Biopsy Needle Kits due to Risk of Microscopic Stainless Steel Debris Inside Needle
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: Elekta Disposable Biopsy Needle Kit Unique Device Identifier (UDI): Package including 6 needles:…
Battery Pack Correction: Smiths Medical Updates Use Instructions for CADD-Solis Li-ion Rechargeable Battery Packs Due to Risk That Pack Damage May Cause a Circuit Short and Prevent Recharge
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…
Children’s Health
Kids aren’t just small adults. From diet and nutrition to their reactions to medicine, their bodies are unique. Read these Consumer Updates to learn more. Content current as of: 12/21/2021 Health Topic(s) Article source: http://www.fda.gov/consumers/consumer-updates/childrens-health
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:…
FDA D.I.S.C.O. Burst Edition: FDA approval of Tecelra (afamitresgene autoleucel) for unresectable or metastatic synovial sarcoma
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer therapeutic approval. On August 2, 2024, the FDA granted accelerated approval to…