Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131
FDA Recall Z-2983-2026 · Posted 2026-08-18
Recalling FirmFort Defiance Industries, LLC
Recall StatusOpen, Classified
Product CodeFLE
Date Initiated2026-07-08
Reason for Recall
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.
Firm Action
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.
Root Cause
Component design/selection
Distribution Pattern
Worldwide - US Nationwide distribution in the states of MD, VA, NJ, TN and the countries of Canada, Lithuania, Spain.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.