Tag: class 1 recall

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Medical Device Recalls Reach Highest Level in Four Years

Sedgwick brand protection releases a year-in-review analysis of 2024 recall data, including the top five failures for medical devices.

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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

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Getinge Subsidiary Recalls Intra-Aortic Balloon Pumps Due to Compromised Materials

Getinge is recalling IABP devices due to a compromised intra-aortic balloon causing blood to enter the IABP during therapy.

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Medical Device Recalls Reach Highest Level in Four Years

Sedgwick brand protection releases a year-in-review analysis of 2024 recall data, including the top five failures for medical devices.

Getinge’s Recall of 11,000 Ventilators Labeled Class I Event by FDA

Aug 29, 2022

Getinge is recalling several different types of ventilators in its device portfolio that are being labeled as a Class I event by the FDA.

Medtronic Recalls Ventricular Assist Device Batteries

Aug 26, 2022

Medtronic is recalling HeartWare Ventricular Assist Device System batteries due to their ability to experience electrical faults that cause them to unexpectedly fail.

Medtronic Recalls Defibrillator Devices for Short Circuit Alert Risks

Aug 22, 2022

Medtronic is recalling Cobalt/Crome implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.

Getinge Recalls Anesthesia Systems for Broken Suction System Power Switches

Jul 7, 2022

Getinge is recalling the Flow-c and Flow-e anesthesia systems after reports of cracked or broken on/off switches on the system’s suction unit.

GE Healthcare Recalls Certain Ventilator Batteries Due to Early Failure Issues

Jun 29, 2022

Backup batteries for GE Healthcare’s CARESCAPE R860 ventilator were recalled because they may run out before they are expected to do so.

Medtronic, Baxter Face FDA Class I Labels for Separate Recalls of Heart Pumps, Ventilators

Jun 27, 2022

Amid continued recall concerns, devices from Medtronic and Baxter were recently assigned the most serious recall type be the FDA.

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Draeger Breathing Filter Gets Class I Recall

The Draeger SafeStar 55 has been identified by the U.S. FDA as a Class I recall, the most serious type of recall.