Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.
Class IIFDA: OngoingPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.
Class IIFDA: OngoingPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Atellica CH Microalbumin_2 (¿ALB_2) and the ADVIA Chemistry Microalbumin_2 (¿ALB_2) are not meeting the High-Dose Hook Effect claim/Prozone Effect claim as stated in the Instructions for…
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices.
Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to undersized Pneumatics Tubing in the reagent storage module causing air leaks, compressor failures or sample…
Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.
Class IIFDA: OngoingPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174,…
During CAPA investigations of sight production inconsistencies, it was highlighted that previous Electromagnetic Compatibility (EMC) assessments related to RF radiated emissions may not be…
Atellica CH Microalbumin_2 (¿ALB_2) and the ADVIA Chemistry Microalbumin_2 (¿ALB_2) are not meeting the High-Dose Hook Effect claim/Prozone Effect claim as stated in the Instructions for…
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174,…
Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential for autonomous cursor motion when Finger Touchscreen capability is enabled by software…
The National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Database (NVD) that NexGen Healthcare Mirth Connect, prior to version 4.4.1, has a…
Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback…
Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.
Class IIFDA: OngoingPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback…
Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback…
Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback…
Packaging material was updated for the Bulb Irrigation Syringe (DYND20125), and additional testing done at Medline Corporate indicated the potential for the sterile barrier to be breached…
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
About the 2024 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.