Blom-Singer Classic Indwelling Voice Prosthesis — Class II medical device recall Z-2909-2026
Ongoing recall by Freudenberg Medical, LLC, reported 2026-08-12, distributed nationwide. Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal F
| Recall number | Z-2909-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Freudenberg Medical, LLC, Carpinteria, CA, United States |
| Recall initiated | 2026-06-17 |
| Classified | 2026-08-06 |
| Reported by FDA | 2026-08-12 |
| Distributed | Nationwide (US) |
| Quantity | 12 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00813307014133 |
| Lot numbers | 0000369233 |
| Model numbers | 1610-LEF |
Product
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
Reason for recall
Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange.
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-2909-2026. 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.