FDA recall, , Moderate risk
Freudenberg Medical Blom-Singer Classic Indwelling Voice Prosthesis
The Blom-Singer Classic Indwelling Voice Prosthesis has incorrect labeling.
Summary by Recall Canary from the FDA notice
What happened
Freudenberg Medical, LLC of Carpinteria, California is recalling Blom-Singer Classic Indwelling Voice Prosthesis products due to 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.
The company began the recall on June 17, 2026, and the FDA added it to the Enforcement Report on August 6, 2026. The products were distributed in the states of IN, OH, AZ, WA, FL, MO, KY, NY and the countries of GBR and FRA.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF
- UDI-DI
- 0000369205
- 00813307014232
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
- UDI-DI
- 0000369233
- 00813307014133
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Indiana, Ohio, Arizona, Washington, Florida, Missouri, Kentucky, Indiana, New York and the countries of GBR, FRA.
- Company
- Freudenberg Medical, LLCCarpinteria, California
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99299
- Recall numbers
- Z-2909-2026 to Z-2910-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
