Blom-Singer Classic Indwelling Voice Prosthesis recall
Freudenberg Medical, LLC recalled Blom-Singer Classic Indwelling Voice Prosthesis on August 12, 2026 because of 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. It was sold nationwide.
Why it was recalled
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's recalled
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
Quantity: 12 units
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Freudenberg Medical, LLC, Carpinteria, CA
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA. - Status
- Ongoing
- Recall number
- Z-2909-2026
- Source
- U.S. Food and Drug Administration
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