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U.S. Department of Health and Human Services

Class 2 Device Recall Fort Defiance Industries, Automated Field Steam Sterilizer

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 Class 2 Device Recall Fort Defiance Industries, Automated Field Steam Sterilizersee related information
Date Initiated by FirmJuly 08, 2026
Date PostedAugust 18, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2983-2026
Recall Event ID 99371
510(K)NumberK141009 
Product Classification Sterilizer, steam - Product Code FLE
ProductFort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131
Code Information Lot Code: All serial numbers/ GTIN: (01) 00862992000327
FEI Number 3011421558
Recalling Firm/
Manufacturer		 Fort Defiance Industries, LLC
2411 Maremont Pkwy
Loudon TN 37774-1066
For Additional Information ContactL. Chris Coleman
+1-865-6576108
Manufacturer 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.
FDA Determined
Cause 2		Component design/selection
ActionBetween 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.
DistributionWorldwide - US Nationwide distribution in the states of MD, VA, NJ, TN and the countries of Canada, Lithuania, Spain.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FLE
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