P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641 — Class II medical device recall Z-0121-2022
Ongoing recall by Fort Defiance Industries, LLC, reported 2021-10-27, distributed nationwide. The rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have suf
| Recall number | Z-0121-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fort Defiance Industries, LLC, Loudon, TN, United States |
| Recall initiated | 2021-08-19 |
| Classified | 2021-10-15 |
| Reported by FDA | 2021-10-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 380 devices |
| Serial numbers | AFS-0001 |
| Model numbers | P2131 |
Product
P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0121-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.