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Lower risk Medical device recall · FDA · Published May 24, 2018

Fort Defiance P2131 Sterilizer Recall: Water Deposits May Affect Gauge

Fort Defiance recalls P2131 sterilizers due to water deposits from long-term storage causing potential issues with rear sight gauge or water level switch. Affected units have serial numbers AFS-0001 to AFS-0199.

🇺🇸 FDA recall #Z-2411-2018Medical deviceFort Defiance ›
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Recalling firmFort Defiance Industries, LLC2411 Maremont Pkwy · Loudon, TN 37774-1066
✎ GovInfoNow plain-language explainer

Fort Defiance is recalling its P2131 Automated Field Steam Sterilizer because stagnant water in long-term storage can create deposits that might interfere with the rear sight gauge or water level switch. This could lead to improper sterilization if the device isn't functioning correctly. Read more at govinfonow.com/recall/70989-fort-defiance-p2131-sterilizer-recall-water-deposits-may-affect-gauge.

Source Summary by GovInfoNow · govinfonow.com/recall/70989-fort-defiance-p2131-sterilizer-recall-water-deposits-may-affect-gauge · Updated August 21, 2026 · FDA enforcement record: FDA #Z-2411-2018

Cite this page

“Fort Defiance P2131 Sterilizer Recall: Water Deposits May Affect Gauge.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/70989-fort-defiance-p2131-sterilizer-recall-water-deposits-may-affect-gauge. Based on FDA recall #Z-2411-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2411-2018%22&limit=1).

The FDA announced on May 24, 2018, that Fort Defiance Industries, LLC voluntarily recalled its P2131 Automated Field Steam Sterilizer due to potential deposits interfering with device function. The recall affects units distributed nationwide in Pennsylvania, Virginia, and Texas.

How to tell if you have it

  • Brand: Fort Defiance
  • Product: FDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER
  • NSN: 6530-01-641-4641
  • Serial Numbers: AFS-0001 through AFS-0199

The hazard

According to the FDA, stagnant water and dissimilar metals in the plumbing of the P2131 device can produce deposits during long-term storage. These deposits may interfere with the rear sight gauge or the water liquid level switch.

Context

GovInfoNow's records show Fort Defiance Industries, LLC has two other recalls on record since August 19, 2021. Other recent recalls of similar products include Medline Convenience Kits Recall: Calibration Issues May Affect Sterility (January 7, 2026), Olympus Toomey Evacuator : Sterilization Risk - Recall 188 (May 5, 2026), and Medline Convenience Kits Recall: Sterility Risk from Calibration Issues (January 7, 2026).

How to tell if you have this one

Check for serial numbers starting with AFS-0001 through AFS-0199 on the device. The P2131 model is designed for sterilizing medical equipment in austere environments.

  • Brand
    Fort Defiance
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Serial Number

    Look for serial numbers starting with AFS-0001 through AFS-0199 on the device.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 3 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: nationwideFL

FDA distribution: “US Nationwide Distribution in the states of PA. VA. TX” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Pennsylvania, Texas, Virginia.

Recall timeline

FDA terminated this recall 5.1 years after the firm started it.

1. Firm started the recall: May 24, 201812. FDA classified it Class II: Jul 10, 201823. Published in FDA’s Enforcement Report: Jul 18, 201834. FDA terminated the recall: Jun 27, 2023420182023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2411-2018 (May 24, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2411-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA