Z-2909-2026 Class II Ongoing
FDA device recall Z-2909-2026 was initiated by Freudenberg Medical, LLC on June 17, 2026 and is designated Class II. Reason for recall: 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 E… The recall status is ongoing. Affected quantity: 12 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 12, 2026
- Initiation Date
- June 17, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 units
Product Description
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA.
Code Information
Lot #0000369233/UDI: 00813307014133