FDAFDA recall Z-2909-2026 · Aug 12, 2026
Freudenberg Medical, LLC: Blom-Singer Classic Indwelling Voice Prosthesis recall
Recall found
Product
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
Reason for recall
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 to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot #0000369233/UDI: 00813307014133
- Quantity
- 12 units
- Distribution
- US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA.
- Recalling firm
- Freudenberg Medical, LLC, Carpinteria, CA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-17
Source: openFDA enforcement record Z-2909-2026 · search recall number Z-2909-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.