Z-2909-2026Class II

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

Name: Z-2909-2026 Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
Creator: Freudenberg Medical, LLC
Published: 2026-06-17
License: https://open.fda.gov/license/

Freudenberg Medical, LLC / initiated 2026-06-17 / Open, Classified / root cause: labeling and UDI

FDA source

Freudenberg Medical, LLC began a recall of Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF on 2026-06-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2909-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-17
Posted: 2026-08-06
Recalling firm: Freudenberg Medical, LLC
Product: Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
Product code: EWL Prosthesis, Laryngeal (Taub)
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: On June 26, 2026, Inhealth Technologies issued a Urgent Medical Device Recall Notification via FedEx to affected consignees. Inhealth ask consignees to take the following actions: 1. Do not use, ship, or distribute affected products 2. Identify and isolate all affected inventory 3. Destroy all affected devices 4. Complete the attached response form 5. Return confirmation no later than: July 8, 2026 6. Email confirmation of product destruction to: [email protected]
Quantity in commerce: 12 units
Distribution: US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA.
Product codes and lots: Lot #0000369233/UDI: 00813307014133

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2909-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2909-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-06
Z-2910-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-06

Product code EWL

K932120Class IIBlom-Singer Indwelling Low Pressure Voice ProsthesHelix Medical, Inc. / cleared 1994-04-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)