Fort Defiance Industries (FDI), Automated Field Steam… recallZ-2983-2026 · Fort Defiance Industries, LLC · initiated Jul 8, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Fort Defiance Industries, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Component design/selection
What the company is doing
Between the dates of July 8, 2026 - July 16, 2026 Fort Defiance Industries (FDI) issued a Urgent Medical Device Recall to affected consignees vi Email. FDI ask consignees to take the following actions: 1. Devices can continue in operation until the fix is implemented. 2. In the interim, users should avoid touching the WRS power connector during operation as a precaution. 3. Please contact FDI and order the upgrade kit complete with instructions to perform this Field Correction. 4. After receiving the kit, please review the instructions and determine if you are competent to perform the update. The instructions will state alternate options to complete the repair (i.e. send to military depot). 5. Perform the repair 6. FDI requests a phone call or e-mail confirmation when the upgrade is completed. This confirmation can be a phone call or e-mail message.
Recall details
- Recall number
- Z-2983-2026
- Status
- Open, Classified
- Initiated by the company
- Jul 8, 2026
- Posted by the FDA
- Aug 18, 2026
- Recalling firm
- Fort Defiance Industries, LLC
- Product code
- FLE
- FDA submissions
- K141009
- Distribution
- Worldwide - US Nationwide distribution in the states of MD, VA, NJ, TN and the countries of Canada, Lithuania, Spain.
Product description
Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131
Code information (models, lots, serial numbers)
Lot Code: All serial numbers/ GTIN: (01) 00862992000327
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NA P2131-2Fort Defiance Industries, LLC · Sterilizer, Steam1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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