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Olympus expands recall of endoscope needles

Olympus has expanded a voluntary recall of its ViziShot 2 FLEX Needles due to complaints of device components ejecting or attaching during procedures, the Food and Drug Administration announced Jan. 16. The company said it received reports of one patient death and one patient injury and advised users to cease use of the product immediately and quarantine all devices. Customers were instructed to return the devices to Olympus. The FDA announced a Class I recall of certain lots of the product in September. 
Recall Management, Supply chain management

FDA identifies, issues Class 1 recalls

The Food and Drug Administration has identified a recall by Cook Medical of Zenith Alpha 2 Thoracic Endovascular Graft proximal components after Cook Medical found that scrapings of polytetrafluoroethylene coating may be released inside the stent graft during use. Impacted components include all length ZTA2-P/PT devices with diameters between 40 mm and 46 mm.
Products, Medical Device Safety

Permanent recall issued for Baxter ventilation system

The Food and Drug Administration has identified a
Recall Management, COVID-19: CDC, FDA and CMS Guidance

FDA issues most serious recall for certain speed control dials used for wheelchairs

The Food and Drug Administration has identified a Class I recall of Max Mobility/Permobil SpeedControl Dials used with the SmartDrive MX2+ Power Assist Device for wheelchairs after identifying a design issue that can lead to unexpected behavior of the SmartDrive motor.
Recall Management

Infant formula recall expands as botulism outbreak cases grow

ByHeart Nov. 13 expanded its voluntary recall to include all Whole Nutrition Infant Formula cans and Anywhere Pack products amid an investigation by the Food and Drug Administration and other agencies of a multistate outbreak of infant botulism illnesses.
Recall Management, Quality & Patient Safety

Recall issued for mislabeled potassium chloride

The Food and Drug Administration yesterday published an
COVID-19: CDC, FDA and CMS Guidance, Recall Management

Most serious FDA recall issued for Abiomed heart pump controllers

The Food and Drug Administration has identified a Class I recall of Abiomed Automated Impella Controllers due to the potential for serious injury or death.
Medical Device Safety

Olympus recalls endoscope needles

The Food and Drug Administration yesterday
Recall Management, COVID-19: CDC, FDA and CMS Guidance

FDA issues serious recall for electric wheelchair joysticks

The Food and Drug Administration has identified a Class I recall for Mo-Vis BVBA R-net
COVID-19: CDC, FDA and CMS Guidance, Medical Device Safety

FDA recalls certain coaxial breathing sets, resuscitators, other products

The Food and Drug Administration has identified Class I recalls for the following products due to the potential for serious injury or death:
Medical Device Safety