CLASS II ONGOING Device recall · Reported 26 Aug 2026 · FDA Enforcement Report
(FDI), Automated Field Steam Sterilizer recalled
Fort Defiance Industries is recalling (FDI), Automated Field Steam Sterilizer, distributed nationwide in the US. The recall was initiated on 8 Jul 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2983-2026
- FDA event ID
- 99371
- Recalling firm
- Fort Defiance Industries, Loudon, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Jul 2026
- FDA classified
- 18 Aug 2026
- Reported
- 26 Aug 2026
- Type
- Voluntary: Firm initiated
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 8 Jul 2026 | Recall initiated by company | |
| 18 Aug 2026 | Classified by FDA | +41 days |
| 26 Aug 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Automated Field Steam Sterilizer's water recovery system 120V Amphenol connector may experience an intermittent loss of ground continuity, which could result in an unreliable fault current return path.
Product as listed by the FDA
Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131
Where it was distributed
Worldwide - US Nationwide distribution in the states of MD, VA, NJ, TN and the countries of Canada, Lithuania, Spain.
Questions about this recall
Why was it recalled?
The Automated Field Steam Sterilizer's water recovery system 120V Amphenol connector may experience an intermittent loss of ground continuity, which could result in an unreliable fault current return path.
Which lots are affected?
Lot Code: All serial numbers/ GTIN: (01) 00862992000327
Where was it sold?
Worldwide - US Nationwide distribution in the states of MD, VA, NJ, TN and the countries of Canada, Lithuania, Spain.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Fort Defiance Industries
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | P2131 Automated Field Steam Sterilizer NSN: 6530 recalled | Fort Defiance Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Fdi Fort Defiance Industries P2131 Automated Field Steam recalled | Fort Defiance Industries | Other | Nationwide |
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