Recall Z-2983-2026— Fort Defiance Industries, LLC

Name: FDA recall Z-2983-2026
Creator: U.S. Food and Drug Administration
Published: 2026-07-08

Class II · Ongoing

Class II FDA medical device recall by Fort Defiance Industries, LLC, initiated 2026-07-08. It names one FDA 510(k) clearance: K141009. Product: Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131. Reason: 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..

Recalling firm: Fort Defiance Industries, LLC
Classification: Class II
Status: Ongoing
Initiated: 2026-07-08
Firm location: Loudon, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K141009 — FORT DEFIANCE AUTOMATED STEAM STERILIZERFort Defiance Industries, Inc.·cleared 2014-12-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.