Official recall notice
FDA DeviceClass IINotable
FDA Recall: Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131
- Recall date
- 2026-08-26
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
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 description
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.
Affected products
Lot Code: All serial numbers/ GTIN: (01) 00862992000327