Recall Ledger

Fort Defiance Industries recall (Fort Defiance Industries, LLC)

Medical deviceClass IIOngoing

Summary: Fort Defiance Industries, LLC is recalling 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.

What is being recalled

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

Why

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.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

Worldwide - US Nationwide distribution in the states of MD, VA, NJ, TN and the countries of Canada, Lithuania, Spain. (states named: Maryland, New Jersey, Tennessee, Virginia)

How to tell if yours is affected

Lot Code: All serial numbers/ GTIN: (01) 00862992000327

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-2983-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedJuly 8, 2026
ReportedAugust 26, 2026
CompanyFort Defiance Industries, LLC
Company locationLoudon, TN, United States
Initiated byVoluntary: Firm initiated

More recalls from Fort Defiance Industries, LLC · all medical device recalls · recalls from July 2026

Official FDA record