August 6, 2025Medical DevicesFDA
Fresenius Kabi USA, LLC recalls LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.
Hazard: Potential for external cassette leaks
August 6, 2025Medical DevicesFDA
Fresenius Kabi USA, LLC recalls LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET-0014-20.
Hazard: Potential for external cassette leaks
August 6, 2025Medical DevicesFDA
Fresenius Kabi USA, LLC recalls LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.
Hazard: Potential for external cassette leaks
August 6, 2025Medical DevicesFDA
3M Company recalls 3M Ranger Irrigation Fluid Warming Set, REF 24750
Hazard: Notice was issued to clarify flow rates related to the inlet fluid temperature.
August 6, 2025Medical DevicesFDA
Siemens Healthcare Diagnostics Inc recalls RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
Hazard: Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500 Systems Wash/Waste Cartridge Lot WW/08925 due to a manufacturing error causing positive and negative bias in Ionized Calcium, Potassium, pH, Chloride, pCO2, Glucose and Lactate analytes and their derivatives. Four complaints were filed related to this event that led to Siemens Healthcare Diagnostics identifying an error in the manufacturing process and initiated corrective actions. Use of the affected device may result in errors during QC which could lead to a delay in patient treatment. If bias generated from this issue is not caught during QC erroneous results may cause temporary or medically reversible adverse health consequences to patients.
August 6, 2025Medical DevicesFDA
Remel, Inc recalls Blood/MacConkey Biplate 100/PK, Product Number R02049
Hazard: The products may contain surface and subsurface contamination of Listeria monocytogenes.
August 6, 2025Medical DevicesFDA
Remel, Inc recalls Blood/EMB, Levine 100/PK, Product Number R02041
Hazard: The products may contain surface and subsurface contamination of Listeria monocytogenes.
August 6, 2025Medical DevicesFDA
Remel, Inc recalls Strep Selective II Agar, Product Number R01859
Hazard: The products may contain surface and subsurface contamination of Listeria monocytogenes.
August 6, 2025Medical DevicesFDA
Remel, Inc recalls Blood Agar,5% Sheep Blood 100/PK, Product Number R01202
Hazard: The products may contain surface and subsurface contamination of Listeria monocytogenes.
August 6, 2025Medical DevicesFDA
Osteotec Limited recalls Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz.
Hazard: There is the potential that the silicone implant may contain foreign material
August 6, 2025Medical DevicesFDA
Volcano Corp recalls Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 8
Hazard: Reports of IVUS catheter and guide wire entanglement during radial-to-peripheral procedures, due to catheter use without appropriate sheath and/or guide catheter, which may require further intervention, such as surgical removal; Firm is restating instructions for use and adding: "Use a guide sheath of appropriate length to provide adequate support to the rapid exchange IVUS catheter and guidewire"
August 6, 2025Medical DevicesFDA
INSTITUT GEORGES LOPEZ recalls Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Pr
Hazard: The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing.
August 6, 2025Medical DevicesFDA
FUJIFILM Healthcare Americas Corporation recalls ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynt
Hazard: Devices had an unapproved slabbing software function enabled for use.
August 6, 2025Medical DevicesFDA
Philips North America recalls Upgrade to MR 7700 Model Number (REF): 782130;
Hazard: The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
August 6, 2025Medical DevicesFDA
Philips North America recalls SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;
Hazard: The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
August 6, 2025Medical DevicesFDA
Philips North America recalls SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;
Hazard: The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
August 6, 2025Medical DevicesFDA
Philips North America recalls SmartPath to dStream for 3.0T Model Number (REF): 782145;
Hazard: The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
August 6, 2025Medical DevicesFDA
Philips North America recalls MR 7700 Model Numbers (REF): (1) 782120, (2) 782153;
Hazard: The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
August 6, 2025Medical DevicesFDA
Philips North America recalls MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;
Hazard: The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
August 6, 2025Medical DevicesFDA
Philips North America recalls Intera 3.0T Quasar Dual Model Number (REF): 781150;
Hazard: The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
August 6, 2025Medical DevicesFDA
Philips North America recalls Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);
Hazard: The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
August 6, 2025Medical DevicesFDA
Philips North America recalls Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);
Hazard: The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
August 6, 2025Medical DevicesFDA
Philips North America recalls Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138;
Hazard: The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
August 6, 2025Medical DevicesFDA
Philips North America recalls Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139;
Hazard: The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
August 6, 2025Medical DevicesFDA
Philips North America recalls Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;
Hazard: The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
August 6, 2025Medical DevicesFDA
Philips North America recalls Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;
Hazard: The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
August 6, 2025Medical DevicesFDA
Philips North America recalls Ingenia 1.5T S Model Number (REF): 781347;
Hazard: The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
August 6, 2025Medical DevicesFDA
Philips North America recalls Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140;
Hazard: The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
August 6, 2025Medical DevicesFDA
Philips North America recalls Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143;
Hazard: The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
August 6, 2025Medical DevicesFDA
Philips North America recalls Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148;
Hazard: The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.