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All product recalls associated with Hitachi Medical Systems America Inc.
Total Recalls
1000
Past Year
88
Class I (Serious)
98
Most Recent
Nov 2025
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard.
Presence of Particulate Matter: Foreign particulate matter (tiny black specs) were observed at the bottom of the vial following reconstitution.
Catheter Connections is recalling DualCap IV Pole Strips disinfectant caps for luer access valves due to potential improper packaging cap seal which may render the sealed cap non-sterile.