eSwallow Multi-Program Dysphagia Therapy Test unit Intended Use: Powered Muscle Stimulator for treatment of dysphagia.

It was discovered that the firm was distributing medical devices without FDA approval.

eSwallow USA LLC sent an URGENT MEDICAL DEVICE RECALL letter dated June 22 2011, via US mail and email notification to each distributors. The letter identified the product, the problem, and the action to be taken. Distributors were instructed to immediately examine inventory, quarantine all product subject to recall, and identify customers that received these products and notify them at once of the recall. The letter advised distributors to forward a copy of the recall notification letter to their customers. The letter states that the distributors are to return all inventories to the eSwallow Corporate Office eSWALLOWusa, 106 Hidden Drive, Scottsboro, Al 35769. The recall should be carried out to the customer/user level. Customers are instructed to complete and return the attached Response Form as soon as possible. If you have any questions, call (256) 571-0443.