The SYSTEM 1E Liquid Sterilant Processing System recallZ-2335-2012 · Steris Corporation · initiated Aug 1, 2012
Class II Terminated All recalls posted in September 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Steris Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
STERIS sent a Urgent Voluntary Field Correction Notice letter dated August 1, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. STERIS has received no reports of injuries associated with the disconnection of a SYSTEM IE water hose. STERIS Corporation will instill new hoses and connections on your SYSTEM IE Liquid Chemical Sterilant Processing System. For further information or if you have any questions regarding our visit to your facility, please contact STERIS Field Service Dispatch at 1-800-333-8828.
Recall details
- Recall number
- Z-2335-2012
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 1, 2012
- Posted by the FDA
- Sep 7, 2012
- Recalling firm
- Steris Corporation
- Quantity
- 6,051 units
- Product code
- MED
- FDA submissions
- K090036, K101409, K102462
- Distribution
- Worldwide Distribution -- USA (nationwide) and the countries of Bahrain and Hong Kong.
Product description
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.
Code information (models, lots, serial numbers)
Model #: P6500, S/N 400000 through 406294
Other devices under the same FDA submission
4 devices cleared under K090036, K101409, K102462 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NA Quick ConnectSteris Corporation · Sterilant, medical devices2 reports
- S40 S4000Steris Corporation · Sterilant, medical devices1 report
- SYSTEM 1E Liquid Chemical Sterilant Processing SystemCorporation Steris Canada · Sterilant, medical devices1 report
- NA Quick ConnectSteris Corporation · Sterilant, medical devices1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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