Freudenberg Medical, Llc: Prosthesis, Laryngeal (taub)
Recall Summary Freudenberg Medical is recalling Blom-Singer Classic Indwelling Voice Prosthesis (model 16Fr/10 mm) because the boxes are labeled incorrectly—some boxes labeled for one type of flange actually contain a different type. This product is a laryngeal prosthesis used by people who have had voice box surgery. The recall affects devices distributed nationwide across multiple states and some international locations.
- Recalling firm
- 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
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-17
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/21496389-6443-484e-86e3-014311538ef8