- Recalling firm
- Grace Medical, Inc.
- Reason for recall
- Due to incorrect functional length on device labeling.
- Affected products (lot / model / serial)
- Model/Catalog Number: 409-375 UDI code: (01)00844505000772(10)122927(17)310301 Lot Number: 122927
- Units affected
- 7
- Distribution pattern
- U.S Nationwide distribution in the state of MD.
- Firm location
- Bartlett, TN, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2308-2026
- Recall initiated
- April 3, 2026
- FDA classification date
- June 4, 2026
- FDA report date
- June 10, 2026
- FDA event ID
- 98773
- Last updated on HTM Vibe
- July 24, 2026