Fresenius Kabi Issues Correction for Ivenix Infusion Pumps Following Impact Damage
The Food and Drug Administration classifies the recall as the most serious type after reports of touchscreen malfunctions caused by dropped or jarred devices.
Category: Recalls
Recalls
Latest
Recalls
Latest
Fresenius Kabi Issues Critical Software Update for Ivenix Infusion Pumps
FDA identifies Class I recall as most serious type due to software anomalies that may cause unexpected shutdowns and interface freezing.
Recalls
Latest
BD Advises Biomed Inspection of Dropped Alaris Pump Modules
The company advises taking any dropped or severely jarred modules out of service and sending them to biomedical engineering for inspection before reuse.
Recalls
Latest
Fresenius Kabi Issues Correction for Ivenix Infusion Pumps Following Impact Damage
The Food and Drug Administration classifies the recall as the most serious type after reports of touchscreen malfunctions caused by dropped or jarred devices.
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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Philips Recalls Reworked CPAP and BiPAP Devices Over Programming Error
Philips Respironics is recalling certain DreamStation Auto CPAP and Auto BiPAP devices due to a programming error introduced during rework by a supplier.
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Medical Device Recalls Hit 20-Year High as FDA Implements AI-Driven Review Process
New Sedgwick report shows Q2 2025 saw highest quarterly Class I medical device recalls in two decades, while agency launches generative AI tool for faster approvals.
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Hamilton Medical Removes Breathing Circuits Over Serious Ventilation Risk
The devices may have cracks that could lead to patient rebreathing of exhaled gases.
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Recalls
Latest
FDA Issues Class I Recall for Ambu Manual Resuscitators
The most serious type of recall was initiated due to a blocked manometer port, which can prevent pressure monitoring and lead to severe patient harm.
