Class IIOngoingZ-2233-2025
Fresenius Kabi USA, LLC recalls LVP Blood Products Administration Set Dual-Inlet
Potential for external cassette leaks
Fresenius Kabi USA, LL…MAAug 6, 2025
Recalls in Massachusetts
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 277–288 of 426 recalls
Class IIOngoingZ-2232-2025
Fresenius Kabi USA, LLC recalls LVP Primary Administration Set
Potential for external cassette leaks
Fresenius Kabi USA, LL…MAAug 6, 2025
Class IIOngoingZ-2230-2025
Siemens Healthcare Diagnostics Inc recalls RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
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,…
Siemens Healthcare Dia…MAAug 6, 2025
Class IIOngoingZ-2219-2025
FUJIFILM Healthcare Americas Corporation recalls ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE…
Devices had an unapproved slabbing software function enabled for use.
FUJIFILM Healthcare Am…MAAug 6, 2025
Class IIOngoingZ-2218-2025
Philips North America recalls Upgrade to MR 7700 Model Number (REF): 782130
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.
Philips North AmericaMAAug 6, 2025
Class IIOngoingZ-2217-2025
Philips North America recalls SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118
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.
Philips North AmericaMAAug 6, 2025
Class IIOngoingZ-2216-2025
Philips North America recalls SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270
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.
Philips North AmericaMAAug 6, 2025
Class IIOngoingZ-2215-2025
Philips North America recalls SmartPath to dStream for 3.0T Model Number (REF): 782145
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.
Philips North AmericaMAAug 6, 2025
Class IIOngoingZ-2214-2025
Philips North America recalls MR 7700 Model Numbers (REF): (1) 782120
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.
Philips North AmericaMAAug 6, 2025
Class IIOngoingZ-2213-2025
Philips North America recalls MR 5300 Model Numbers (REF): (1) 782110
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.
Philips North AmericaMAAug 6, 2025
Class IIOngoingZ-2212-2025
Philips North America recalls Intera 3.0T Quasar Dual Model Number (REF): 781150
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.
Philips North AmericaMAAug 6, 2025
Class IIOngoingZ-2211-2025
Philips North America recalls Ingenia Elition X Model Numbers (REF): (1) 781358
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.
Philips North AmericaMAAug 6, 2025