Class II

Medical Device Recall: Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF

Freudenberg Medical, LLC · June 17, 2026

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

US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA.

States Affected

NATIONWIDE

Quantity Affected

40 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2910-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Freudenberg Medical, LLC Medical Device Recall: Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF | SafeCheck