The SYSTEM 1E Liquid Sterilant Processing System — Class II medical device recall Z-2335-2012
Terminated recall by Steris Corporation, reported 2012-09-19, distributed nationwide. The firm initiated a recall after complaint investigations revealed that when the units are left on and not in
| Recall number | Z-2335-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Steris Corporation, Mentor, OH, United States |
| Recall initiated | 2012-08-01 |
| Classified | 2012-09-07 |
| Reported by FDA | 2012-09-19 |
| Terminated | 2014-06-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | BH, HK |
| Quantity | 6,051 units |
| Reason classes | packaging |
| Model numbers | 400000, P6500 |
Product
The SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.
Reason for recall
The firm initiated a recall after complaint investigations revealed that when the units are left on and not in use at night and/or on weekends the hose disconnects/separates resulting in water leakage that can cause damage to property.
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-2335-2012. 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.