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Fort Defiance Automated Steam Sterilizer

by Fort Defiance Industries, Inc. 510(k)

Active United States Open recall

510(k) K141009

Regulatory status

as of 28 Oct 2026

Recall ongoing. 2 ongoing FDA recalls name this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK141009 Date16 Dec 2014ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

3 recalls · 2 ongoing · FDA

    • Ongoing Z-2983-2026 FDA Class II initiated 8 Jul 2026

    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.

    • Ongoing Z-0121-2022 FDA Class II initiated 19 Aug 2021

    The rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground.

    • Terminated Z-2411-2018 FDA Class II initiated 24 May 2018

    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.

Specification

510(k)

510(k) Number
FDA Product Code
FLE
Device Class
Class II
Regulation
21 CFR Part 880.6880
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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