The Recall Desk
HighFDA (Devices)·Z-2983-2026·Announced 2026-08-26

Fort Defiance Automated Field Steam Sterilizer Recalled for Electrical Grounding Defect

Fort Defiance Industries is recalling Automated Field Steam Sterilizers because a water recovery system connector may lose ground continuity, creating an unreliable fault current return path.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of electrical shock (unreliable fault current return path) where no specific injuries or hospitalizations are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Fort Defiance Industries, LLC is recalling the Automated Field Steam Sterilizer (REF: P2131) due to a potential electrical safety defect. The recall is classified as Class II by the U.S. Food and Drug Administration.

The defect involves the water recovery system's 120V Amphenol connector, which may experience an intermittent loss of ground continuity. This issue could result in an unreliable fault current return path, posing a risk of electrical shock or equipment malfunction.

The affected units were distributed worldwide, including nationwide in the United States (specifically Maryland, Virginia, New Jersey, and Tennessee) and in Canada, Lithuania, and Spain. All serial numbers are affected. Users should stop using the device and contact Fort Defiance Industries for instructions on repair or replacement.

The recalled product

Product
Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131
Manufacturer
Fort Defiance Industries, LLC
Category
Medical Device — Sterilization Equipment
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Code: All serial numbers/ GTIN: (01) 00862992000327

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

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