FDA recall, , Moderate risk
Fort Defiance Industries Automated Field Steam Sterilizer
The Automated Field Steam Sterilizer may have an intermittent loss of ground continuity in its water recovery system connector.
Summary by Recall Canary from the FDA notice
What happened
Fort Defiance Industries, LLC, of Loudon, Tennessee, recalled its Automated Field Steam Sterilizer REF: P2131 on July 8, 2026, because the water recovery system 120V Amphenol connector may experience an intermittent loss of ground continuity, which could result in an unreliable fault current return path.
The recall was added to the FDA's Enforcement Report on August 18, 2026, and in FDA's weekly enforcement report on August 26, 2026. The product was distributed in Maryland, New Jersey, Tennessee, and Virginia, as well as in Canada, Lithuania, and Spain.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131
- UDI-DI
- 00862992000327
- Lot code
- All serial numbers/ GTIN: (01) 00862992000327
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of Maryland, Virginia, New Jersey, Tennessee and the countries of Canada, Lithuania, Spain.
- Company
- Fort Defiance Industries, LLCLoudon, Tennessee
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99371
- Recall number
- Z-2983-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
