Fort Defiance Industries, LLC P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641
Brand
Fort Defiance Industries, LLC
Lot Codes / Batch Numbers
Model number: P2131, NSN: 6530-01-641-4641, Serial Numbers AFS-0001 through AFS-0386. Note: AFS-0297 was not manufactured.
Products Sold
Model number: P2131; NSN: 6530-01-641-4641; Serial Numbers AFS-0001 through AFS-0386. Note: AFS-0297 was not manufactured.
Fort Defiance Industries, LLC is recalling P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641 due to The rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground.
Recommended Action
Per FDA guidance
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."
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026