medical MODERATE Updated 2026-08-12

Freudenberg Medical, LLC recalls Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm

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Recalled Product

Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF

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Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #0000369233/UDI: 00813307014133

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

Search Amazon for Blom-Singer Classic Indwelling Voice →

If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.

View official government recall

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