AUDIENCE: Patient, Health Care Professional, Neurology ISSUE: The FDA is warning that the antinausea patch Transderm Scōp (scopolamine transdermal system) can increase body temperature and cause heat-related complications, resulting in hospitalization or even death in some cases. Most cases occurred in children 17 years and younger and in adults 60 years and older, who may…
Convenience Kit Recall: Medline Industries, LP, Removes Medline Neonatal and Pediatric Kits containing Smiths Medical ORAL/NASAL Endotracheal Tubes Due to Smaller Than Expected Tube Diameter That May Cause Underventilation
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 Products Product Name Product Code UDI NEONATAL INTUBATION TRAY ACC010371C 10193489268188 NEWBORN RESUSCITATION KIT ACC010381A 10193489800944 …
Blood Products Administration Set Recall: Fresenius Kabi Removes Large Volume Pump Blood Products Administration Sets due to Incorrect Assembly
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 Part Number UDI-DI Lot Number LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site,…
Aspiration Catheter Recall: Q’Apel Medical, Inc. Removes Hippo 072 Aspiration System and Cheetah Delivery Tool After FDA Warning Letter About Internal Processes and Distal Tip Characteristics
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 Products Product Names: 072 Aspiration System or Hippo 072 Aspiration System including Cheetah Delivery Tool and…
Infusion Pump Recall: Zyno Medical Removes Certain Z-800 Series Infusion Pumps due to Software Issue
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 Affected Serial Numbers for Z-800 (UDI-DI: 00814377102006) 800242 801925 802867 900875 901058 901089 901101 901126…
Intra-Operative Positioning System Guidewire Recall: Centerline Biomedical Removes Certain IOPS Guidewires due to Delamination
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 Device Name Model Number UDI-DI Lot Number IOPS Guidewire ATW-2 H01035 00843152102051 2404-2005 What to…
Liquid Bicarbonate Concentrate Recall: Nipro Removes MedicaLyte Liquid Bicarbonate Concentrate due to Contamination
This recall involves removing 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 MedicaLyte Liquid Bicarbonate Concentrate – 45x Proportioning (BC+201) Unique Device Identifier (UDI)/Model: 00817411022824 What to Do…
Anesthesia Breathing Circuit Kit Correction: Draeger, Inc. Updates Use Instructions for VentStar Flex and Anesthesia Circuit Kits Due to Cracks in Hose That May Cause Inadequate 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 Part No. Product Name UDI-DI Potential Affected Lots MP00355 VentStar Flex 220 04048675248996 All Lot…
Medtronic Announces Voluntary Recall of Select Newport™ HT70 and Newport™ HT70 Plus Ventilators and Certain Related Newport™ Service Parts
Summary Company Announcement Date: June 11, 2025 FDA Publish Date: June 11, 2025 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Device & Drug Safety – Potential Defect Company Name: Medtronic Brand Name: Brand Name(s) Newport™ Product Description: Product Description Newport™ HT70 and HT70 Plus ventilators and certain related service parts Company Announcement…
Infusion Pump Recall: Infusion Pump Intermittent Connection Issue from Smiths Medical
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 The FDA is aware that Smiths…