Freudenberg Medical, LLC 2026-08-12 Health serious FDA
Health · FDA · Recall #FDA-Z-2909-2026
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF Recall
Issued August 12, 2026 · Freudenberg Medical, LLC
In August 2026, Freudenberg Medical, LLC recalled the Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF, a serious health recall reported by the FDA.
Compiled by Dana Whitfield, RecallCheckr
What this means for you
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 you should do
- 1 Stop using Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Freudenberg Medical, LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Freudenberg Medical, LLC
- Category
- Health
- Recall date
- August 12, 2026
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA.
- Recall number
- FDA-Z-2909-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Freudenberg Medical, LLC has 2 recalls in our database.
- We're tracking 3,707 Health recalls in our database.
- This is the 487th Health recall we've logged in 2026.