Nova Biomedical Pulls StatStrip Gen 2.0 Glucose Meters Over Patient ID Errors
A software issue can cause glucose results to be assigned to the wrong patient's medical record. One serious injury has been reported, and a fix is expected in November.
Category: Recalls
Recalls
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Recalls
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FDA Issues Alert for Medtronic Esophageal Monitoring Devices
The agency warns of potential high-risk issues with Bravo CF delivery systems following reports of 184 serious injuries.
Recalls
Latest
FDA Recall Issued for Ivenix Infusion Pump Software Due to Shutdown Risk
The company is advising users to keep devices plugged into AC power following a software anomaly that may cause false battery readings and unexpected shutdowns.
Recalls
Latest
Nova Biomedical Pulls StatStrip Gen 2.0 Glucose Meters Over Patient ID Errors
A software issue can cause glucose results to be assigned to the wrong patient's medical record. One serious injury has been reported, and a fix is expected in November.
GAO Report Finds FDA Struggles to Meet Medical Device Recall Termination Goals
The agency exceeded its three-month termination timeline for 74% of recalls during fiscal years 2020-2024, due to staff constraints that limited oversight activities, the report finds.
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Fresenius Kabi Removes Ivenix Large-Volume Pumps
A misassembly defect in a specific lot of Ivenix primary administration sets could cause reverse flow, delayed infusion, or serious patient harm, prompting a Class I recall.
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Baxter Removes Sigma Spectrum Infusion System Platforms
The removal is tied to incorrect software installations that could result in inaccurate flow rates and user confusion during clinical use.
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Draeger Pulls Certain ErgoStar Catheter Mounts After Reports of Hose Cracking
The company is asking facilities to stop using affected mounts and return unused stock; cracks can cause leakage that may restrict ventilation if uncompensated.
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FDA Flags Recall Involving IMRIS MRI Systems Linked to Siemens 3T Magnet Issue
The recall affects IMPRIS Neuro III-SV models that use Siemens 3T magnets, citing a risk of blocked helium venting during a magnet quench.
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FDA Issues Recall Early Alert for Olympus Single-Use Ligating Devices
Olympus has updated use instructions after reports that the ligation loop may not release as expected, potentially requiring emergency intervention.
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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.
