FDA Medical devices recall ·
Fort Defiance Industries (FDI), Automated Field Steam Sterilizer recall
- Recall number
- Z-2983-2026
- Date
- (initiated July 8, 2026)
- Company / brand
- Fort Defiance Industries, LLC
2411 Maremont Pkwy, Loudon, TN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
States: Maryland New Jersey Tennessee Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2983-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.