FDA Device recall Z-2910-2026
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF
- FDA Device
- Class II
- ongoing
- Published 2026-08-12
On 2026-08-12 the FDA classified a Class II recall of Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF by Freudenberg Medical, citing 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 Flan….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2910-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-17 |
| Published | 2026-08-12 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Freudenberg Medical |
| Distribution | US |
Product
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF
Reason
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.
Identifiers
| code_info | Lot #0000369205/UDI: 00813307014232 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2910-2026%22
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