Facility

FORT DEFIANCE INDUSTRIES LLC

3 recall(s) on record — most severe on record: Class II.

Key facts

3recalls · worst Class II

2inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3011421558
Establishment type	Manufacture Medical Device
Location	2411 MAREMONT PKWY Loudon, TN, US 37774
Registration status	Active · expires 2026
Parent company	FORT DEFIANCE INDUSTRIES (owner-operator 10048347)
Brand names	P2131 Sterilizer; P2131 Field Steam Sterilizer; P2131 Steam Sterilizer; P2131 Automated Field Steam Sterilizer; Automated Field Steam Sterilizer; P2131

Activity by year

Recalls (3)
Inspections (2)

Devices registered here (1)

Sterilizer, Steam
Product code FLE (opens in a new tab) · Class II · General Hospital · 21 CFR 880.6880

Recalls & enforcement

Class IIOngoing2026-07-08
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.
Class IIOngoing2021-08-19
The rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground.
Class IITerminated2018-05-24
During long-term storage (i.e. military depot), the interaction of stagnant water and dissimilar metals in the plumbing of the P2131 device produces deposits in the water system that can potentially interfere with the rear sight gauge and / or the water liquid level switch.

FDA inspections (2)

NAI2025-11-06
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2017-11-15
No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by FORT DEFIANCE INDUSTRIES

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “FORT DEFIANCE INDUSTRIES LLC (FEI 3011421558) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3011421558-fort-defiance-industries-llc/

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