Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF
FDA device recall Z-2910-2026 · posted 2026-08-06 · Open, Classified
Recall details
- Recalling firm
- Freudenberg Medical, LLC
- 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.
- Action taken
- 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: regulatoryaffairs@freudenbergmedical.com
- Root cause
- Labeling mix-ups
- Status
- Open, Classified
- Product code
- EWL
- Quantity affected
- 40 units
- Distribution
- US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA.
- Date initiated
- 2026-06-17
- Date posted
- 2026-08-06
- Location
- Carpinteria, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES (K932120) | Helix Medical, Inc. | 1994-04-15 |