Z-0121-2022Class II

P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641

Name: Z-0121-2022 P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641
Creator: Fort Defiance Industries, LLC
Published: 2021-08-19
License: https://open.fda.gov/license/

Fort Defiance Industries, LLC / initiated 2021-08-19 / Open, Classified / root cause: design

FDA source

Fort Defiance Industries, LLC began a recall of P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641 on 2021-08-19. FDA classified it as Class II and gives the reason as "The rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground". 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-0121-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-08-19
Posted: 2021-10-16
Recalling firm: Fort Defiance Industries, LLC
Product: P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641
Product code: FLE Sterilizer, Steam
Reason for recall: The rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground.
Root cause tag: design
FDA 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 in commerce: 380 devices
Distribution: Distributed nationwide to PA, MD, TX, NJ, OH, TN, UT, VA and internationally to Canada.
Product codes and lots: Model number: P2131; NSN: 6530-01-641-4641; Serial Numbers AFS-0001 through AFS-0386. Note: AFS-0297 was not manufactured.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0121-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0121-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-10-27	2021-10-15

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 2026-09-05. View this recall on fda.gov (opens on fda.gov)