The U.S. Food and Drug Administration (FDA) today issued a formal written request to Shelhigh, Inc. to recall all of its medical devices remaining in the marketplace, including hospital inventories, because of sterility concerns.
On April 17, 2007, U.S. Marshals, at FDA's request, seized all medical devices including components at Shelhigh's Union, N.J. facility after finding significant deficiencies in the company's manufacturing processes. During the seizure, Shelhigh was asked to perform a voluntary recall of its products, but the company declined.
