Fort Defiance Industries, Inc.
United StatesFDA applicant, unverified
- Devices
- 9
- FDA recalls
- 32 ongoing
At a glance
Market reach
- United States
- FDA recalls
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Regimes: 510(k) Registry: 510(k)
FRONT-LINE Field Sterilizer (FL135) Ref K243801
Regimes: 510(k) Registry: 510(k)Fort Defiance Automated Steam Sterilizer Ref K141009
Regimes: 510(k) Registry: 510(k)
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 1
- 2019 0
- 2020 0
- 2021 1
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 1
2026
- 8 Jul 2026 Z-2983-2026 Class II Ongoing 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.
2021
- 19 Aug 2021 Z-0121-2022 Class II Ongoing The rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground.
2018
- 24 May 2018 Z-2411-2018 Class II Terminated 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.
Frequently asked questions
How many devices does Fort Defiance Industries, Inc. have in the registry?
The registry currently lists 9 devices for Fort Defiance Industries, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Fort Defiance Industries, Inc.'s devices?
Among its 9 most recently registered devices, Fort Defiance Industries, Inc. has devices listed in FDA 510(k) (3 devices) and FDA GUDID (6 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Fort Defiance Industries, Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Fort Defiance Industries, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Fort Defiance Industries, Inc.?
FDA recall records list 3 recalls initiated by Fort Defiance Industries, Inc., the most recent initiated on 2026-07-08. 2 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Fort Defiance Industries, Inc. in the registry?
The most recently registered devices listed for Fort Defiance Industries, Inc. include NA FRONT-LINE FL135, NA P2131-3, NA FRONT-LINE FL120 and NA P2131-2.