Blom-Singer Classic Indwelling Voice Prosthesis
Blom-Singer Classic Voice Prosthesis recalled due to incorrect labeling of flange types.
Check the labeling on your Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm (REF 1610-LEF) to ensure the flange type matches the label. If the contents do not match the label, stop using the product and contact Freudenberg Medical for a replacement.
Why it was recalled
Freudenberg Medical is recalling the Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm (REF 1610-LEF) due to incorrect labeling. The box labeled for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the box labeled for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange, which may lead to improper use.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF
| Product | Lot code | Recall # | UDI-DI |
|---|---|---|---|
| 1610-LF | 0000369205 | Z-2910-2026 | 0000369205, 00813307014232 |
| 1610-LEF | 0000369233 | Z-2909-2026 | 0000369233, 00813307014133 |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Labeling Error recalls
Editorial summary by Recall Canary · summary updated 2026-08-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification