FDA Medical Device Recalls (openFDA)
Fort Defiance Industries, LLC: P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641
- Recall number
- Z-0121-2022
- Recalling firm
- Fort Defiance Industries, LLC
- Product
- P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641
- Status
- Open, Classified
- Initiated
- 2021-08-19
- Posted
- not on file
- Terminated
- not on file
- Reason
- The rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground.
- Root cause
- Device Design
- Action
- A Recall notification letter titled, "MEDICAL DEVICE ADVISORY NOTICE" was sent to consignees on 08/19/2021 via a email. The notice provides instructions regarding continued use of the device until FDI provides a protective cover for the rear heater plate and cover assembly. It mentions, "THE OPERATOR SHOULD NOT TOUCH THE REAR HEATER PLATE AND COVER ASSEMBLY OF THE DEVICE WHILE THE DEVICE IS IN USE OR POWERED ON. IF ACCESS TO THE REAR OF THE DEVICE IS REQUIRED, PLEASE TURN THE POWER OF THE UNIT OFF USING THE FRONT PANEL SWITCH OR DISCONNECT INCOMING POWER TO THE DEVICE. DO NOT ATTEMPT TO MODIFY THE DEVICE TO CHANGE THE ELECTRICAL GROUND CONDITION OF THE HEATER PLATE AND COVER ASSEMBLY AS THIS WILL IMPACT DEVICE PERFORMANCE."
- Quantity
- 380 devices
- Distribution
- Distributed nationwide to PA, MD, TX, NJ, OH, TN, UT, VA and internationally to Canada.
- Lot, serial or model codes
- Model number: P2131; NSN: 6530-01-641-4641; Serial Numbers AFS-0001 through AFS-0386. Note: AFS-0297 was not manufactured.
- 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