Study Finds Defect Risk in Low-Cost Lithium-Ion Batteries
A new report highlights quality control gaps and potential safety hazards from non-OEM 18650 cells, which are used in some medical devices.
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Search Results for: recall
3M Company Corrects Ranger Blood/Fluid Warming System
The action addresses a discrepancy between the device’s labeled and actual performance at high flow rates, which could pose a risk of patient hypothermia.
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FDA Alerts Users to Purge Pressure Issues in Automated Impella Controller
The alert links purge retainer failures to potential pump stops and loss of hemodynamic support; the manufacturer is planning a service update.
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Class I Recall Expanded for Alaris Pump Infusion Sets
The voluntary recall involves certain infusion sets used with the BD Alaris Pump Module model 8100 due to performance deviations that could impact dose accuracy.
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Tandem Issues Correction for t:slim X2 Insulin Pumps
A faulty speaker wire can cause a malfunction that halts insulin delivery, prompting the US Food and Drug Administration to classify the action as a Class I recall.
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