Class IIOngoingZ-1985-2026
DEPUY (IRELAND) recalls Depuy Synthes
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
DEPUY (IRELAND)May 6, 2026
All device recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 709–720 of 4,586 recalls
Class IIOngoingZ-1984-2026
Immuno-Mycologics, Inc recalls Immy
Neutralization Buffer may contain contaminants
Immuno-Mycologics, IncOKMay 6, 2026
Class IIOngoingZ-1983-2026
Becton Dickinson & Co. recalls BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use
BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.
Becton Dickinson & Co.MDMay 6, 2026
Class IIOngoingZ-1982-2026
Becton Dickinson & Co. recalls BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use
BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.
Becton Dickinson & Co.MDMay 6, 2026
Class IIOngoingZ-1980-2026
Siemens Healthcare Diagnostics, Inc. recalls Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential imprecision in the Dimension CRE2 quality control (QC) and patient sample resul…
Siemens Healthcare Dia…DEMay 6, 2026
Class IIOngoingZ-1969-2026
Philips North America recalls Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE s…
Philips North AmericaMAMay 6, 2026
Class IIOngoingZ-1968-2026
Philips North America recalls Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number…
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE s…
Philips North AmericaMAMay 6, 2026
Class IIOngoingZ-1967-2026
Philips North America recalls Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model N…
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE s…
Philips North AmericaMAMay 6, 2026
Class IIOngoingZ-1966-2026
Philips North America recalls Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (…
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE s…
Philips North AmericaMAMay 6, 2026
Class IIOngoingZ-1965-2026
Philips North America recalls Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (…
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE s…
Philips North AmericaMAMay 6, 2026
Class IIOngoingZ-1964-2026
Philips North America recalls Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. M…
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE s…
Philips North AmericaMAMay 6, 2026
Class IIOngoingZ-1963-2026
Philips North America recalls Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358…
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE s…
Philips North AmericaMAMay 6, 2026