FDA Device recall Z-0128-2014
Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3
- FDA Device
- Class III
- terminated
- Published 2013-11-13
On 2013-11-13 the FDA classified a Class III recall of Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3 by Helix Medical, citing 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 ATS….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0128-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-10-01 |
| Published | 2013-11-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Helix Medical |
| Distribution | US |
Product
Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3
Reason
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.
Identifiers
| code_info | LOTS: 1057760, 1057919 and 1059222 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0128-2014%22
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