Official recall notice
FDA DeviceClass IINotable
FDA Recall: Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
- Recall date
- 2026-08-12
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
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.
Product description
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.
Affected products
Lot #0000369233/UDI: 00813307014133