Helix Medical LLC: Medical Device Recall in 2013 - (Recall #: Z-0128-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3

Product Classification:

Class III

Date Initiated: October 1, 2013

Date Posted: November 13, 2013

Recall Number: Z-0128-2014

Event ID: 66423

Reason for Recall:

InHealth Technologies (IHT) is recalling the Blom-Singer Adjustable Tracheostoma Valve II (ATSV II) because the body component of the device is missing from the packaging. The ATSV II Valve product cannot be used as intended without the product body.

Status: Terminated

Product Quantity: 47 units

Code Information:

LOTS: 1057760, 1057919 and 1059222

Distribution Pattern:

Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Croatia, Germany, Ireland, and Italy.

Voluntary or Mandated:

Voluntary: Firm initiated