Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and… — Class III medical device recall Z-0128-2014
Terminated recall by Helix Medical LLC, reported 2013-11-13, distributed nationwide. InHealth Technologies (IHT) is recalling the Blom-Singer Adjustable Tracheostoma Valve II (ATSV II) because th
| Recall number | Z-0128-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Helix Medical LLC, Carpinteria, CA, United States |
| Recall initiated | 2013-10-01 |
| Classified | 2013-11-01 |
| Reported by FDA | 2013-11-13 |
| Terminated | 2014-01-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA, DE, HR, IE, IT |
| Quantity | 47 units |
| Lot numbers | 1057760, 1057919, 1059222 |
| Model numbers | BE8025H, BE8025H-R3 |
Product
Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0128-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.