Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131
Summary
The FDA issued a Class II for Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131 by Fort Defiance Industries, LLC. Reason: The Automated Field Steam Sterilizer's water recovery system 120V Amphenol connector may experience an intermittent loss of ground continuity, which c.
Details
Source
Device Recall
External ID
Z-2983-2026
Action Date
2026-08-26
Status
Ongoing
Category
device
Product Description
Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131
Lot/Code Info: Lot Code: All serial numbers/ GTIN: (01) 00862992000327
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-08
Company
Loudon, TN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 149 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Fort Defiance Industries, LLC has 4 FDA actions in our database, including 2 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Fort Defiance Industries, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Fort Defiance Industries, LLC have FDA actions?
Fort Defiance Industries, LLC has 4 FDA actions in our database, including 2 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2983-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29