Food, drugs, devices › Fort Defiance Industries, LLC
Device recall: Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131
Fort Defiance Industries, LLC (Loudon, TN) initiated this device recall on 8 Jul 2026; FDA lists 1 product record under event 99371, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 572 device enforcement events initiated in 2026 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Fort Defiance Industries, LLC has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Fort Defiance Industries, LLC, Loudon, TN.
Reason for recall
"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."
Distribution
"Worldwide - US Nationwide distribution in the states of MD, VA, NJ, TN and the countries of Canada, Lithuania, Spain."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2983-2026 | Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131 | — | Class II | Ongoing | 26 Aug 2026 |
Context
Other enforcement events for Fort Defiance Industries, LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 19 Aug 2021 | P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641 | Device | Class II | 1 |
| 24 May 2018 | FDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER, NSN: 6530-01-641-4641 Product Usage: The Fort Defia | Device | Class II | 1 |
All 3 events for Fort Defiance Industries, LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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 does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide - US Nationwide distribution in the states of MD, VA, NJ, TN and the countries of Canada, Lithuania, Spain."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.