The Recall Desk
HighFDA (Devices)·Z-0121-2022·Announced 2021-10-27

FDA Recalls P2131 Automated Field Steam Sterilizer for Electrical Grounding Defect

Fort Defiance Industries is recalling the P2131 Automated Field Steam Sterilizer because the rear heater assembly lacks sufficient electrical grounding, creating a shock hazard. The recall affects 380 devices distributed nationwide and to Canada.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II recall involves a risk-of-harm product with an electrical grounding defect that could cause shock injury. No illnesses or injuries have been reported, placing this at the high-risk threshold where injury has not yet occurred.

Plain-English summary

Fort Defiance Industries, LLC is recalling the P2131 Automated Field Steam Sterilizer (Model P2131, NSN 6530-01-641-4641) due to a defect in the electrical assembly. The rear heater plate and cover assembly, which contains the electrical wiring for the heaters, does not have sufficient bonding to ground.

This defect creates a potential electrical shock hazard to users. Approximately 380 devices are affected, including serial numbers AFS-0001 through AFS-0386 (excluding AFS-0297, which was not manufactured). These devices were distributed nationwide to Pennsylvania, Maryland, Texas, New Jersey, Ohio, Tennessee, Utah, Virginia, and internationally to Canada.

The FDA has classified this as a Class II recall. If you own or operate an affected sterilizer, discontinue use immediately and contact Fort Defiance Industries for instructions on inspection, repair, or replacement. Do not attempt to repair the device yourself.

The recalled product

Product
P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641
Manufacturer
Fort Defiance Industries, LLC
Category
Medical Device — Sterilization Equipment
Hazard
Affected units
380

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

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