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.
In addition, the FDA issued early alerts today for certain Olympus High Flow Insufflation Units and all Integra LifeSciences MediHoney Wound and Burn products and certain lots of CVS Wound Gel.
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