---
title: "Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF — FDA record Z-2909-2026 | Is It on Recall"
description: "Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophagea"
url: https://isitonrecall.com/recall/fda-device-z-2909-2026-blom-singer-classic-indwelling-voice-prosthesis-16fr-10-mm-ref-1610-lef/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF — FDA record Z-2909-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jun 17, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
- **Reason**: 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.
- **Classification**: Class II
- **Recalling firm**: Freudenberg Medical, LLC
- **Quantity**: 12 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-2909-2026

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2909-2026%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Lot #0000369233/UDI: 00813307014133 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

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## Dates in the source

- **Report date**: Aug 12, 2026
- **Recall initiation date**: Jun 17, 2026
- **Center classification date**: Aug 6, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2909-2026%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Freudenberg Medical, Llc records](https://isitonrecall.com/brand/freudenberg-medical-llc/)