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Open, Classified

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

FDA Recall Z-2910-2026 · Posted 2026-08-06

Recalling FirmFreudenberg Medical, LLC
Recall StatusOpen, Classified
Product CodeEWL
Date Initiated2026-06-17
Product Quantity40 units

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.

Firm 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]

Root Cause

Labeling mix-ups

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K932120BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHESHelix Medical, Inc. · 1994-04-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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