Chrysalis Intelligence · Sponsors · Fort Defiance Industries, LLC

Fort Defiance Industries, LLC

Loudon, TN, US · 2 510(k) clearances · 2 recalls

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Total clearances

2

2022-03-02 → 2025-03-07

Last 12 months

0

Product codes

1

Most recent

2025-03-07

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
FLE	Sterilizer, Steam	Class II	General Hospital	2	2025-03-07

Safety

Recalls (2)

Class I (serious)

0

Risk of injury / death

Total recalls

2

Currently ongoing

2

Most recent

2026-07-08

Date	Severity	Status	Recall #	Product	Code	Reason
2026-07-08	Class II	Ongoing	Z-2983-2026	Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131	—	The Automated Field Steam Sterilizer's water recovery system 120V Amphenol connector may experience an intermittent loss of ground continuity, which could resul…
2021-08-19	Class II	Ongoing	Z-0121-2022	P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641	—	The rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground.

Filings

All 510(k) clearances (2)

Date	K-number	Device	Code	Class	Specialty
2025-03-07	K243801	FRONT-LINE Field Sterilizer (FL135)	FLE	Class II	General Hospital
2022-03-02	K213457	Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135	FLE	Class II	General Hospital