SYSTEM 1E Liquid Chemical Sterilant Processing System… recallZ-3124-2011 · Steris Corporation · initiated Aug 11, 2011
Terminated All recalls posted in September 2011
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
STERIS learned that SYSTEM 1E users may experience aborted cycles due to a failure within the UV light system.
FDA root cause category: Other
What the company is doing
STERIS sent an "Urgent Field Correction Notice" letter dated July 2011 to all affected customers. The letter describes the product, problem and actions to be taken. The letter states that STERIS Service Representative will contact customers to schedule the repair of the recalled product. For further information or questions contact STERIS Field Service Dispact at 1-800-333-8828.
Recall details
- Recall number
- Z-3124-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 11, 2011
- Posted by the FDA
- Sep 1, 2011
- Recalling firm
- Steris Corporation
- Quantity
- 2,235 units
- Product code
- MLR
- FDA submissions
- K090036, K101409, K102462
- Distribution
- Worldwide Distribution - USA (nationwide) and the country of Bahrain.
Product description
SYSTEM 1E Liquid Chemical Sterilant Processing System, Model # P6500, S/N: 400001 through 405005; Mfr. By: STERIS Corporation, Mentor, OH 44060. Product Usage: The SYSTEM 1E Liquid Chemical 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: 400001 through 405005
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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