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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- 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
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