- Recalling firm
- DeRoyal Industries Inc
- Reason for recall
- Sterile wound dressing, lacks sterility assurance
- Affected products (lot / model / serial)
- Lot: 63295141/UDI: None
- Units affected
- 800 units
- Distribution pattern
- US Nationwide distribution in the states of FL & NC.
- Firm location
- Powell, TN, United States
- Recall type
- Voluntary: Firm initiated
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2305-2026
- Recall initiated
- May 18, 2026
- FDA classification date
- June 3, 2026
- FDA report date
- June 10, 2026
- FDA event ID
- 99044
- Last updated on HTM Vibe
- July 23, 2026