FDA Medical Device Recalls (openFDA)
Fort Defiance Industries, LLC: Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131
- Recall number
- Z-2983-2026
- Recalling firm
- Fort Defiance Industries, LLC
- Product
- Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131
- Status
- Open, Classified
- Initiated
- 2026-07-08
- Posted
- 2026-08-18
- Terminated
- not on file
- 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.
- 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.
- Quantity
- not on file
- Distribution
- Worldwide - US Nationwide distribution in the states of MD, VA, NJ, TN and the countries of Canada, Lithuania, Spain.
- Lot, serial or model codes
- Lot Code: All serial numbers/ GTIN: (01) 00862992000327
- 510(k) numbers
- ["K141009"]
- PMA numbers
- not on file
- Product code
- FLE
- Firm FEI
- 3011421558
- Firm city
- Loudon
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28