Fort Defiance Industries, LLC: Medical Device Recall in 2018 - (Recall #: Z-2411-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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 is 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 use in a variety of austere environments.

Product Classification:

Class II

Date Initiated: May 24, 2018

Date Posted: July 18, 2018

Recall Number: Z-2411-2018

Event ID: 80293

Reason for Recall:

During long-term storage (i.e. military depot), the interaction of stagnant water and dissimilar metals in the plumbing of the P2131 device produces deposits in the water system that can potentially interfere with the rear sight gauge and / or the water liquid level switch.

Status: Terminated

Product Quantity: 199 units

Code Information:

Serial Numbers: AFS-0001 through AFS-0199

Distribution Pattern:

US Nationwide Distribution in the states of PA. VA. TX

Voluntary or Mandated:

Voluntary: Firm initiated