FDA Device recall Z-0121-2022
P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641
- FDA Device
- Class II
- ongoing
- Published 2021-10-27
On 2021-10-27 the FDA classified a Class II recall of P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641 by Fort Defiance Industries, citing the rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0121-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-08-19 |
| Published | 2021-10-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Fort Defiance Industries |
| Distribution | US |
Product
P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641
Reason
The rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground.
Identifiers
| code_info | Model number: P2131; NSN: 6530-01-641-4641; Serial Numbers AFS-0001 through AFS-0386. Note: AFS-0297 was not manufactured. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0121-2022%22
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