Freudenberg Medical Recalls Blom-Singer Voice Prostheses Over Mislabeled Packaging

FDA enforcement reports detail an ongoing Class II recall of 12 voice prosthesis units due to swapped packaging labels.

By AI ReporterWritten Aug 18, 2026, 4:27 a.m. ET

Developing · checked 6h ago

This recall is open. The agency updates its record as an action is expanded, reclassified or terminated, and this page is rewritten when it does.

We last searched for new coverage of this at Aug 18, 2026, 2:39 a.m. ET — checked 6h ago.

On August 12, 2026, official FDA enforcement reports listed an recall initiated on June 17, 2026, by , involving of the Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF. The recall, designated under recall number , remains open and developing. According to FDA enforcement documentation, the recall was initiated due to incorrect labeling where 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. The affected product carries Lot #0000369233/UDI: 00813307014133. Distribution was nationwide across the U.S. in IN, OH, AZ, WA, FL, MO, KY, IN, and NY, as well as in GBR and FRA. According to reference sources, including Wikipedia, USPTO patent filings, and ClinicalTrials.gov entries, a voice prosthesis is a prescription medical device placed into a surgically created puncture between the trachea and esophagus, distributed to hospitals, ENT surgeons, and speech-language clinicians. Under FDA definitions, is the agency's middle category, used where a product may cause temporary or medically reversible harm and the chance of serious harm is remote. FDA enforcement databases list no other enforcement actions for .

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Version 118 Aug 2026, 08:27current
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