Class II U.S. Food and Drug Administration

Freudenberg Medical, LLC Blom-Singer Classic Indwelling Voice Prosthesis recall: Incorrect labeling- The labeled box for the Large Esophageal Flange contains

Recall published 2 months ago

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.

The hazard: Mislabelling or misbranding

The product and the packaging do not match. For most people that is an annoyance; for anyone reading the label for a medical reason it is a genuine risk.

What the notice says: 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.

Why it matters: The product carries the wrong label, the wrong lid or the wrong packaging. The food inside is generally fine; the problem is that the package describes something else, which defeats anyone relying on it.

Symptoms and when to call a doctor

There is no illness associated with mislabelling itself. The exception is where the undeclared contents include an allergen, in which case treat it as an allergen recall and watch for the reaction that person normally has.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-2910-2026
Published
August 12, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Freudenberg Medical, LLC
Product type
Medical devices
Units affected
40 units
Distribution
Nationwide
Made in
United States
Lot / code info
Lot #0000369205/UDI: 00813307014232
UPC codes
00813307014232

Products covered by this recall

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

Check your product

The notice names 5 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00813307014232

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 0000369205
  • UDI

Model or item number

On the rating label, the box or the instruction sheet.

  • 1610-LF — Lot #0000369205
  • UDI

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Mislabelled

Freudenberg Medical, LLC — The product and the packaging do not match. For most people that is an annoyance; for anyone reading the label for a medical reason it is a genuine risk.

  1. Read the official notice to see what is actually inside the pack, then decide whether anyone in your home needs to avoid it.
  2. If the undeclared contents include an allergen, treat it as an allergen recall and stop serving it to anyone affected.
  3. Return it for a refund; a mislabelled pack is returnable whether or not it is edible for your household.
  4. Keep a photo of the mismatched label, which makes the refund conversation much shorter.

Getting a refund without the pack

The commonest reason people skip the refund is that they have already thrown the item away. That rarely matters.

  • A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.
  • Store credit is often offered first. You can ask for the original payment method instead, and it is normally granted.
  • No photo either? Ask anyway. Grocery chains settle recall refunds at the service desk because disputing them costs more than paying them.
  • For a multi-pack or a case, ask for the full purchase price rather than a per-unit figure — the recall covers what you paid.

Company contact: Freudenberg Medical, LLC — 1110 Mark Ave, Carpinteria, CA, 93013-2918

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Freudenberg Medical, LLC medical devices 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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00813307014232; lot code 0000369205, UDI; model number 1610-LF — Lot #0000369205, UDI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Read the official notice to see what is actually inside the pack, then decide whether anyone in your home needs to avoid it.

Can I get my money back?

A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.

Where was the recalled product sold?

It was distributed nationwide.

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