BLOM-SINGER indwelling TEP Occluder — Class III medical device recall Z-2336-2012
Terminated recall by Helix Medical LLC, reported 2012-09-19, distributed nationwide. Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date.
| Recall number | Z-2336-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Helix Medical LLC, Carpinteria, CA, United States |
| Recall initiated | 2012-03-08 |
| Classified | 2012-09-07 |
| Reported by FDA | 2012-09-19 |
| Terminated | 2013-04-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | GB |
| Quantity | 2 devices |
| Lot numbers | 1008419 |
| Model numbers | IN2004-TO |
Product
BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Indwelling (TEP(tracheoesophageal Puncture) Occluder is a non-valved silicone prosthesis designed for placement in and maintenance of the TE (tracheoesophageal) puncture following total laryngectomy. The Blom-Singer Indwelling TEP (tracheoesophageal Puncture) Occluder is indicated for placement in and maintenance of the TE puncture following total laryngectomy when placement, or replacement, of an indwelling prosthesis is performed by a qualified, trained medical professional.
Reason for recall
Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date.
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-2336-2012. 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.