FDA Medical devices recall ·
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm recall
- Recall number
- Z-2909-2026
- Date
- (initiated June 17, 2026)
- Company / brand
- Freudenberg Medical, LLC
1110 Mark Ave, Carpinteria, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 12 units
- Hazard tags
- Mislabeling
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
Why was it 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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #0000369233/UDI: 00813307014133
Distribution
US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA.
States: Arizona Florida Indiana Kentucky Missouri New York Ohio Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2909-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.