Recall Z-2910-2026— Freudenberg Medical, LLC

Name: FDA recall Z-2910-2026
Creator: U.S. Food and Drug Administration
Published: 2026-06-17

Class II · Ongoing

Class II FDA medical device recall by Freudenberg Medical, LLC, initiated 2026-06-17. It names one FDA 510(k) clearance: K932120. Product: Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF. 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..

Recalling firm: Freudenberg Medical, LLC
Classification: Class II
Status: Ongoing
Initiated: 2026-06-17
Firm location: Carpinteria, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K932120 — BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHESHelix Medical, Inc.·cleared 1994-04-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.