Z-2983-2026Class II

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

Name: Z-2983-2026 Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131
Creator: Fort Defiance Industries, LLC
Published: 2026-07-08
License: https://open.fda.gov/license/

Fort Defiance Industries, LLC / initiated 2026-07-08 / Open, Classified / root cause: design

FDA source

Fort Defiance Industries, LLC began a recall of Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131 on 2026-07-08. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2983-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-08
Posted: 2026-08-18
Recalling firm: Fort Defiance Industries, LLC
Product: Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131
Product code: FLE Sterilizer, Steam
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: 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.
Distribution: Worldwide - US Nationwide distribution in the states of MD, VA, NJ, TN and the countries of Canada, Lithuania, Spain.
Product codes and lots: Lot Code: All serial numbers/ GTIN: (01) 00862992000327

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2983-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2983-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-26	2026-08-18

Product code FLE

K141009Class IIFort Defiance Automated Steam SterilizerFort Defiance Industries, Inc. / cleared 2014-12-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-12. View this recall on fda.gov (opens on fda.gov)