FDA Medical Device Recalls (openFDA)
Freudenberg Medical, LLC: Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF
- Recall number
- Z-2910-2026
- Recalling firm
- Freudenberg Medical, LLC
- Product
- Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF
- Status
- Open, Classified
- Initiated
- 2026-06-17
- Posted
- 2026-08-06
- Terminated
- not on file
- 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.
- 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: regulatoryaffairs@freudenbergmedical.com
- 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.
- Lot, serial or model codes
- Lot #0000369205/UDI: 00813307014232
- 510(k) numbers
- ["K932120"]
- PMA numbers
- not on file
- Product code
- EWL
- Firm FEI
- 2025182
- Firm city
- Carpinteria
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28