Z-2880-2011

eSwallow Multi-Program Dysphagia Therapy Test unit

Name: Z-2880-2011 eSwallow Multi-Program Dysphagia Therapy Test unit
Creator: eSwallow USA LLC
Published: 2011-06-22
License: https://open.fda.gov/license/

Eswallow USA / initiated 2011-06-22 / Terminated

FDA source

eSwallow USA LLC began a recall of eSwallow Multi-Program Dysphagia Therapy Test unit Intended Use: Powered Muscle Stimulator for treatment of dysphagia on 2011-06-22. The reason FDA records is "It was discovered that the firm was distributing medical devices without FDA approval". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2880-2011
Status: Terminated
Initiated: 2011-06-22
Posted: 2011-07-25
Terminated: 2012-07-03
Recalling firm: Eswallow USA
Product: eSwallow Multi-Program Dysphagia Therapy Test unit Intended Use: Powered Muscle Stimulator for treatment of dysphagia.
Product code: IPF Stimulator, Muscle, Powered
Reason for recall: It was discovered that the firm was distributing medical devices without FDA approval.
FDA root cause: Other
Action: 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.
Quantity in commerce: 123 units
Distribution: Nationwide (USA) Distribution - including states of AL, AZ, CA, GA, FL, LA, MS, and VA.
Product codes and lots: all lot numbers

Product code IPF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)