- 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.
- Affected products (lot / model / serial)
- Lot #0000369205/UDI: 00813307014232
- Units affected
- 40 units
- Distribution pattern
- US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA.
- Firm location
- Carpinteria, CA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2910-2026
- Recall initiated
- June 17, 2026
- FDA classification date
- August 6, 2026
- FDA report date
- August 12, 2026
- FDA event ID
- 99299
- Last updated on HTM Vibe
- August 18, 2026