Blom-Singer Classic Indwelling Voice Prosthesis recall (Freudenberg Medical, LLC)
Medical deviceClass IIOngoing
Summary: Freudenberg Medical, LLC is recalling 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.
What is being recalled
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA. (states named: Arizona, Florida, Indiana, Kentucky, Missouri, New York, Ohio, Washington)
How to tell if yours is affected
Lot #0000369233/UDI: 00813307014133
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2909-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | June 17, 2026 |
| Reported | August 12, 2026 |
| Company | Freudenberg Medical, LLC |
| Company location | Carpinteria, CA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 12 units |
More recalls from Freudenberg Medical, LLC · all medical device recalls · recalls from June 2026