FDAFDA · Food and drugs·Recall number Z-2909-2026
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
Published August 12, 2026 · Recall initiated: June 17, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Freudenberg Medical, LLC
- Distributor
- US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA.
- Lot
- Lot #0000369233/UDI: 00813307014133
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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