Medical Device Recall Events Drop 5% as Affected Units Surge 517%
The number of medical devices affected by recalls reached a five-year high in the first half of 2026, according to Sedgwick’s latest Recall Index.
Tag: class 1 recall
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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 Announces Class I Recall for ICU Medical Infusion Pump
A software flaw that may cause the Plum Duo Infusion System to become unresponsive has prompted a device correction, which the FDA has identified as its most serious recall type.
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Medical Device Recall Events Drop 5% as Affected Units Surge 517%
The number of medical devices affected by recalls reached a five-year high in the first half of 2026, according to Sedgwick’s latest Recall Index.
Olympus Recalls Bronchoscopes for Burn Risk
Olympus is recalling certain bronchofiberscopes and bronchovideoscopes because they may lead to burns or catch fire.
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Hamilton Medical Inc. Recalls Ventilators Due to Critical Software Issue
Hamilton Medical Inc. has issued a Class I recall, the most serious category, for Hamilton-C1, C2, C3, and T1 ventilators due to a critical software glitch that can abruptly halt operation after 91 days without restarting.
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Certain Draeger Medical Ventilators Get Class I Recall
Certain Draeger ventilators reportedly stopped ventilation because of a depleted battery, even after being re-connected to AC power.
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Johnson & Johnson Megadyne Electrodes Nab Class 1 Recall
The FDA has labeled the recall of two types of Megadyne electrodes manufactured by Johnson & Johnson’s Ethicon as a class I, the most serious.
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Infusion System Replacement Batteries Get FDA Class I Recall
These infusion system replacement batteries were recalled because a defect has diminished how long they can be used to run the system, which may cause the system to shut down an ongoing infusion.
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Fresenius Kabi Recalls Ivenix Infusion System
Fresenius Kabi has issued a voluntary recall of the Ivenix Infusion System due to a leak in the system that allows fluid to enter the administration set loading area near the air detector.
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Avanos Medical Recalls Closed Suction Systems for Young Children
The FDA has identified Avanos Medical’s recall of certain airway access devices for children, infants, and neonates as a Class I recall
