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Freudenberg Medical, LLC: Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF

Medical DevicesSource: FDA (device) · Date: 2026-08-12

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Freudenberg Medical, LLC
Product
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA.
Recall initiated
2026-06-17
Code info
Lot #0000369233/UDI: 00813307014133
Product quantity
12 units
Voluntary mandated
Voluntary: Firm initiated
City
Carpinteria
State
CA
Country
United States
Event id
99299
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