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Fort Defiance Industries, LLC: Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131

Medical DevicesSource: FDA (device) · Date: 2026-08-26

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Fort Defiance Industries, LLC
Product
Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131
Reason / hazard
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.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide - US Nationwide distribution in the states of MD, VA, NJ, TN and the countries of Canada, Lithuania, Spain.
Recall initiated
2026-07-08
Code info
Lot Code: All serial numbers/ GTIN: (01) 00862992000327
Voluntary mandated
Voluntary: Firm initiated
City
Loudon
State
TN
Country
United States
Event id
99371
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