Reported Aug 12, 2026 · Ongoing · Updated Sep 16, 2026
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF
Freudenberg Medical, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Freudenberg Medical, LLC · 1110 Mark Ave · Carpinteria, CA · 93013-2918
Is this the product you have?
- Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10
- mm REF1610-LF
- Lot codes and dates
- Lot #0000369205/UDI: 00813307014232
- Amount recalled
- 40 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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