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.
Related News Articles
Headline
The Food and Drug Administration has issued early alerts for the following products: • Certain epidural kits by Medical Action…
Headline
The Food and Drug Administration has identified a Class I recall of certain Medline convenience kits containing B. Braun components that have Huons Bupivacaine…
Headline
The Food and Drug Administration Aug. 3 identified Class I recalls of two convenience kit products. Certain kits by Medline…
Headline
The Food and Drug Administration has identified Class I recalls of two products: certain Astral ventilators by Resmed due to a supercapacitor that may leak…
Headline
Baxter is voluntarily recalling a specific lot of intravenous solution due to a report of particulate matter in the solution identified as cardboard, according…
Headline
The U.S. Trade Representative yesterday announced it is implementing a 10% or 12.5% tariff on 60 trading partners, which became effective today. These…