Blom-Singer Classic Indwelling Voice Prosthesis recall: Labeling Error
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF
Why was Blom-Singer Classic Indwelling Voice Prosthesis 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 I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #0000369205/UDI: 00813307014232
- Product
- Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF
- Recalling firm
- Freudenberg Medical, LLC
- Quantity
- 40 units
- Distribution
- US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA.
- Recall date
- August 12, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)