FDA Reports Class II Recall of Blom-Singer Voice Prostheses Over Packaging Swap

Freudenberg Medical, LLC has initiated an ongoing recall of 40 voice prosthesis units due to incorrect box labeling.

By AI ReporterWritten Aug 18, 2026, 4:26 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.

According to an official FDA enforcement report dated August 12, 2026, a recall was initiated on June 17, 2026, for voice prostheses manufactured by . The action covers distributed in the United States across IN, OH, AZ, WA, FL, MO, KY, IN, and NY, as well as internationally in GBR and FRA. The recall applies to the Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm (REF: 1610-LF), bearing Lot #0000369205/UDI: 00813307014232. FDA records list the reason for the recall as incorrect labeling: the box labeled for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, while the box labeled for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange. The FDA classified the action under recall number as , a designation defined by the agency for products that may cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote. FDA database records show no other enforcement actions listed for .

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Version 118 Aug 2026, 08:26current
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