Recall Z-2910-2026
Freudenberg Medical, LLC · initiated June 17, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF
Codes / lots: Lot #0000369205/UDI: 00813307014232
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.
FDA-determined cause: Labeling mix-ups
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
Details
- Recall number
- Z-2910-2026
- Initiated
- June 17, 2026
- Posted by FDA
- August 6, 2026
- Product code
- EWL – Prosthesis, Laryngeal (Taub)
- Quantity
- 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.
- Recalling firm
- Freudenberg Medical, LLC, Carpinteria, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2909-2026 Class II | Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEFIncorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal… | 06/17/2026Open, Classified |