FDA Device recall Z-2335-2012
The SYSTEM 1E Liquid Sterilant Processing System
- FDA Device
- Class II
- terminated
- Published 2012-09-19
On 2012-09-19 the FDA classified a Class II recall of The SYSTEM 1E Liquid Sterilant Processing System by Steris, citing 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 resul….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2335-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-08-01 |
| Published | 2012-09-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Steris |
| Distribution | US |
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
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.
Identifiers
| code_info | Model #: P6500, S/N 400000 through 406294 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2335-2012%22
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