Fort Defiance Industries, LLC recalls Fort Defiance Industries (FDI)

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.

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.

• FDA enforcement recordOfficial FDA database entry for Z-2983-2026
• FDA 510(k) clearance · K141009The device's official FDA premarket clearance record
• FDA device classification · FLEOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.6880The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Fort Defiance Industries, LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.