CLASS II ONGOING Device recall · Reported 27 Oct 2021 · FDA Enforcement Report
P2131 Automated Field Steam Sterilizer NSN: 6530 recalled
Fort Defiance Industries is recalling P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641, distributed nationwide in the US. The recall was initiated on 19 Aug 2021 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-0121-2022
- FDA event ID
- 88628
- Recalling firm
- Fort Defiance Industries, Loudon, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Aug 2021
- FDA classified
- 15 Oct 2021
- Reported
- 27 Oct 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 19 Aug 2021 | Recall initiated by company | |
| 15 Oct 2021 | Classified by FDA | +57 days |
| 27 Oct 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641
Where it was distributed
Distributed nationwide to PA, MD, TX, NJ, OH, TN, UT, VA and internationally to Canada.
Nationwide MarylandNew JerseyOhioPennsylvaniaTennesseeTexasUtahVirginia
Questions about this recall
Why was it recalled?
The rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground.
Which lots are affected?
Model number: P2131; NSN: 6530-01-641-4641; Serial Numbers AFS-0001 through AFS-0386. Note: AFS-0297 was not manufactured.
Where was it sold?
Distributed nationwide to PA, MD, TX, NJ, OH, TN, UT, VA and internationally to Canada.
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 | Fdi Fort Defiance Industries P2131 Automated Field Steam recalled | Fort Defiance Industries | Other | Nationwide |
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| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |