Device recall
Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131
- Recall number
- Z-2983-2026
- Event id
- 99371
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Fort Defiance Industries, LLC
- Report date
- Aug 26, 2026
- Posted
- Aug 18, 2026
- Initiated
- Jul 8, 2026
- Center classification date
- Aug 18, 2026
- Product code
- FLE
- Device type
- Sterilizer, Steam
- Reason
- The Automated Field Steam Sterilizer's water recovery system 120V Amphenol connector may experience an intermittent loss of ground continuity, which could result in an unreliable fault current return path.
- Root cause
- Component design/selection
- Code info
- Lot Code: All serial numbers/ GTIN: (01) 00862992000327
- Distribution
- Worldwide - US Nationwide distribution in the states of MD, VA, NJ, TN and the countries of Canada, Lithuania, Spain.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K141009
- Location
- Loudon, TN, United States