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React Health Removes VOCSN V+Pro Ventilators

A manufacturing error may lead to undetected oxygen leaks, posing risks of reduced oxygen delivery and potential fire hazards.

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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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Philips Respironics Updates Use Instructions for Certain BiPAP Devices

Updated guidance addresses ventilator inoperative alarm failures that may lead to therapy loss, with 13 injuries and eight deaths reported.

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React Health Removes VOCSN V+Pro Ventilators

A manufacturing error may lead to undetected oxygen leaks, posing risks of reduced oxygen delivery and potential fire hazards.

Hamilton Medical Inc. Recalls Ventilators Due to Critical Software Issue

Aug 31, 2023

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.

Certain Draeger Medical Ventilators Get Class I Recall

Jul 14, 2023

Certain Draeger ventilators reportedly stopped ventilation because of a depleted battery, even after being re-connected to AC power.

Johnson & Johnson Megadyne Electrodes Nab Class 1 Recall

Jul 13, 2023

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.

Infusion System Replacement Batteries Get FDA Class I Recall

May 22, 2023

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.

Fresenius Kabi Recalls Ivenix Infusion System

Apr 25, 2023

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.

Avanos Medical Recalls Closed Suction Systems for Young Children

Apr 21, 2023

The FDA has identified Avanos Medical’s recall of certain airway access devices for children, infants, and neonates as a Class I recall

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Getinge Subsidiary’s Intra-Aortic Balloon Pumps Get Class I Recall

Getinge subsidiary Datascope is recalling two types of Intra-Aortic Balloon Pumps due to the possibility of unexpected device shutdown.

Tag: class 1 recall

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