CLASS II ONGOING Device recall · Reported 12 Aug 2026 · FDA Enforcement Report

Blom-Singer Classic Indwelling Voice Prosthesis recalled

Freudenberg Medical is recalling Blom-Singer Classic Indwelling Voice Prosthesis, distributed nationwide in the US. The recall was initiated on 17 Jun 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #0000369233/UDI: 00813307014133

Quantity recalled12 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2909-2026
FDA event ID: 99299
Recalling firm: Freudenberg Medical, Carpinteria, CA
Classification: Class II
Status: Ongoing
Recall initiated: 17 Jun 2026
FDA classified: 6 Aug 2026
Reported: 12 Aug 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

17 Jun 2026	Recall initiated by company
6 Aug 2026	Classified by FDA	+50 days
12 Aug 2026	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

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

Where it was distributed

US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA.

Nationwide Arizona Florida Indiana Kentucky Missouri New York Ohio Washington

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot #0000369233/UDI: 00813307014133

Where was it sold?

US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 99299

Reported	Class	Recall	Company	Reason	Where
12 Aug 2026	CLASS II	Blom-Singer Classic Indwelling Voice Prosthesis recalled	Freudenberg Medical	Labeling Errors	Nationwide

More recalls from Freudenberg Medical

All 4

Reported	Class	Recall	Company	Reason	Where
12 Aug 2026Device	CLASS II	Blom-Singer Classic Indwelling Voice Prosthesis recalled	Freudenberg Medical	Labeling Errors	Nationwide
4 May 2022Device	CLASS II	Empower Introducer Sheath with Hydrophilic Coating 21F recalled	Freudenberg Medical	Other	GA
4 May 2022Device	CLASS II	Empower Introducer Sheath with Hydrophilic Coating 21F recalled	Freudenberg Medical	Other	GA

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