Fort Defiance Industries, LLC: Medical Device Recall in 2021 - (Recall #: Z-0121-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 19, 2021

Date Posted: October 27, 2021

Recall Number: Z-0121-2022

Event ID: 88628

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.

Status: Ongoing

Product Quantity: 380 devices

Code Information:

Model number: P2131; NSN: 6530-01-641-4641; Serial Numbers AFS-0001 through AFS-0386. Note: AFS-0297 was not manufactured.

Distribution Pattern:

Distributed nationwide to PA, MD, TX, NJ, OH, TN, UT, VA and internationally to Canada.

Voluntary or Mandated:

Voluntary: Firm initiated