Heart Pump Accessory Removal: Abbott Removes HeartMate Mobile Power Unit due to Instances of Sudden Power Loss<br> <br>
Posted On: Thu, 24 Apr 2025 14:20:00 EDTFDA is alerting health care providers and lab staff of reports of false positives when using certain Micro Capillary Blood Collection tubes with the LeadCare Testing Systems.
Posted On: Thu, 24 Apr 2025 12:00:00 EDTThis communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
Posted On: Fri, 18 Apr 2025 12:52:00 EDTThis communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
Posted On: Fri, 18 Apr 2025 10:25:00 EDTOn April 7, 2025, the U.S. Food and Drug Administration (“FDA” or “the agency”), classified Q’Apel Medical, Inc.’s (“Q’Apel” or “the company”) voluntary recall of 1,617 units of its 072 Aspiration System (also known under the product name “Hippo”, which includes “Cheetah”; collectively, the “product
Posted On: Fri, 18 Apr 2025 00:00:00 EDTBridgewater, NJ, Amneal Pharmaceutical LLC, is recalling two lots of Ropivacaine Hydrochloride Injection, USP, 500mg/100mL, Infusion bags to the hospital/user level as the products may contain an inert fiber identified as polypropylene fibers from the IV bag. <br>
Posted On: Fri, 18 Apr 2025 00:00:00 EDTMax Mobility/Permobil has expanded the recall of the Speed Control Dial, a wired control option for the SmartDrive MX2+ Power Assist Device due to safety and performance concerns. The recall was originally initiated on December 20, 2024, and has been expanded to address recalled product that may hav
Posted On: Mon, 07 Apr 2025 00:00:00 EDTBausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced a voluntary recall of intraocular lenses (IOLs) on its enVista platform.
Posted On: Mon, 07 Apr 2025 00:00:00 EDTUse of Baxter MiniCap Extended Life PD Transfer Sets during peritoneal dialysis may expose patients to higher than allowable NDL-PCBAs.
Posted On: Mon, 31 Mar 2025 00:00:00 EDTThe FDA expanded its evaluation of the potential risk of exposure to toxic compounds when using hemodialysis and peritoneal dialysis systems
Posted On: Mon, 31 Mar 2025 00:00:00 EDTAortic Root Cannulas are used during heart surgery. There is a risk of extra material in the device due to a manufacturing error.
Posted On: Mon, 31 Mar 2025 00:00:00 EDTRead the FDA’s recommendations related to four recalls of Megadyne Mega 2000 and Mega Soft patient return electrodes for patient burn injuries.
Posted On: Wed, 26 Mar 2025 00:00:00 EDTMegadyne is updating the instructions and product labeling to reflect that the Mega Soft Universal pads should not be used in patients under 12 years old.
Posted On: Wed, 26 Mar 2025 00:00:00 EDTORAL/NASAL Endotracheal Tubes keep air flowing through a patient’s airway, but some tubes may be smaller in diameter than expected.
Posted On: Tue, 25 Mar 2025 00:00:00 EDTSoftware from Alaris System Manager and CCE Infusion Adapter needs updates so outdated infusion information does not load to the Alaris infusion pump system.
Posted On: Thu, 20 Mar 2025 00:00:00 EDTThis communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
Posted On: Thu, 20 Mar 2025 00:00:00 EDTThis communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
Posted On: Thu, 20 Mar 2025 00:00:00 EDTThis communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
Posted On: Thu, 20 Mar 2025 00:00:00 EDTA manufacturing error may cause ProPort Plastic Implantable Ports, which are used in patients who need repeat venous access for treatment, to separate before, during, or after implantation.
Posted On: Wed, 19 Mar 2025 00:00:00 EDTPipeline Vantage Embolization Devices block off blood flow to intracranial aneurysms. Some devices do not attach properly or fail to stay attached.
Posted On: Tue, 18 Mar 2025 00:00:00 EDT