Freudenberg Medical, LLC recalls Blom-Singer Classic Indwelling Voice Prosthesis
- Recalling company
- Freudenberg Medical, LLC
- Product
- Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
- Reason
- 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 – may cause temporary or medically reversible health consequences
- Recall date
- Jun 17, 2026
- Reported
- Aug 12, 2026
- Distribution
- US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA.
- Status
- Ongoing
- Quantity
- 12 units
- Lot / codes
- Lot #0000369233/UDI: 00813307014133
- Company location
- Carpinteria, CA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2909-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2909-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.