CLASS II Device recall · Reported 18 Jul 2018 · FDA Enforcement Report
Fdi Fort Defiance Industries P2131 Automated Field Steam recalled
Fort Defiance Industries is recalling Fdi Fort Defiance Industries P2131 Automated Field Steam Sterilizer, Nsn: 6530-01-641-4641, distributed nationwide in the US. The recall was initiated on 24 May 2018 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-2411-2018
- FDA event ID
- 80293
- Recalling firm
- Fort Defiance Industries, Loudon, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 May 2018
- FDA classified
- 10 Jul 2018
- Reported
- 18 Jul 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 24 May 2018 | Recall initiated by company | |
| 10 Jul 2018 | Classified by FDA | +47 days |
| 18 Jul 2018 | 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
During long-term storage (i.e. military depot), the interaction of stagnant water and dissimilar metals in the plumbing of the P2131 device produces deposits in the water system that can potentially interfere with the rear sight gauge and / or the water liquid level switch.
Product as listed by the FDA
FDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER, NSN: 6530-01-641-4641 Product Usage: The Fort Defiance Industries Automated Field Steam Sterilizer Model P2131 is designed for sterilization of porous and non-porous, heat- and moisture-stable materials (e.g., surgical instruments and textiles) used in healthcare facilities. The P2131 sterilizer is a transportable device designed for use in a variety of austere environments.
Where it was distributed
US Nationwide Distribution in the states of PA. VA. TX
Questions about this recall
Why was it recalled?
During long-term storage (i.e. military depot), the interaction of stagnant water and dissimilar metals in the plumbing of the P2131 device produces deposits in the water system that can potentially interfere with the rear sight gauge and / or the water liquid level switch.
Which lots are affected?
Serial Numbers: AFS-0001 through AFS-0199
Where was it sold?
US Nationwide Distribution in the states of PA. VA. TX
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 | (FDI), Automated Field Steam Sterilizer recalled | Fort Defiance Industries | Other | Nationwide |
| Device | CLASS II | P2131 Automated Field Steam Sterilizer NSN: 6530 recalled | Fort Defiance Industries | Device Malfunction | Nationwide |
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