FDAHealthJune 17, 2026
Freudenberg Medical, LLC — Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 17, 2026
US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA.
What's affected?
- Product
- Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
- Lot code
- 0000369233/UDI:
Additional details
Lot #0000369233/UDI: 00813307014133
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 12 units.
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