FDA recall Z-2983-2026

Fort Defiance Industries, LLC · Class II · device

Product

Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131

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.

Distribution

Worldwide - US Nationwide distribution in the states of MD, VA, NJ, TN and the countries of Canada, Lithuania, Spain.

Key facts

Status
Ongoing
Initiation date
2026-07-08
Report date
2026-08-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Loudon, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2983-2026