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NA P2131-2Recalls & reported problems

Fort Defiance Industries, LLC · The P2131-2 Water Recovery System (WRS) is the water recycling and vacuum source component of the P2131 Automated Field Sterilizer system. The WRS reclaims hot condensate and exhaust steam for re-use by the sterilizer. The WRS also includes a water eductor, which provides the vacuum capability for the pre and post-vacuum phases of sterilization. The P2131 is an automated, pre- and post-vacuum steam sterilizer designed for sterilization of porous and non-porous, heat- and moisture-stable materials (e.g., surgical instruments and textiles) used in healthcare facilities. The P2131 sterilizer is a transportable device designed for field use in a variety of austere environments. The P2131 sterilizer consists of three components that work together as one integrated system. These components are the (1) Sterilizer Main Unit (SMU), (2) Water Recovery System (WRS), and (3) the Sterilizer Water Softener (SWS). · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K141009); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Jul 8, 2026Open, Classified

    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.

    Z-2983-2026 · Root cause: Component design/selection · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141009. One submission often covers many models, so check the product and lot details in each record.

  • Z-0121-2022 · Aug 19, 2021 · Open, Classified
    P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641
  • Z-2411-2018 · May 24, 2018 · Terminated
    FDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER, NSN: 6530-01-641-4641 Product Usage: The Fort Defiance Industries Automated Field Steam Sterilizer Model P2131

Other Sterilizer, Steam devices

All Sterilizer, Steam devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.