SYSTEM 1E Liquid Chemical Sterilant Processing System… recallZ-0616-2014 · Steris Corporation · initiated Nov 21, 2013
Class II Terminated All recalls posted in December 2013
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
Customers indicated fluctuations in environmental conditions sites and gradual degradation/deformation of check valve o-rings following frequent contact with S40 sterilant use solution result in nuisance aborts.
FDA root cause category: Device Design
What the company is doing
STERIS sent an Urgent Voluntary Field Correction Notice dated November 21, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that a STERIS Field Service Representative would contact their facility to schedule installation of the new hardware and updated software on their SYSTEM IE Liquid Chemical Sterilant Processing System(s). Customers were instructed that they may continue to operate the SYSTEM IE processor prior to the completion of the update. Customers with questions were instructed to contact STERIS Field Service Dispatch at 1-800-333-8828. For questions regarding this recall call 440-392-7519.
Recall details
- Recall number
- Z-0616-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 21, 2013
- Posted by the FDA
- Dec 31, 2013
- Recalling firm
- Steris Corporation
- Quantity
- 6,028 units
- Product code
- MLR
- FDA submissions
- K090036, K101409, K102462, K113520, K131078
- Distribution
- Nationwide Distribution - USA (nationwide) and the District of Columbia and Puerto Rico. Product was also shipped to the following countries: Afghanistan, Bahrain, Hong Kong, Italy, Saudi Arabia, Turkey & United Kingdom.
Product description
SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH 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 #6500 & 7500
Other devices under the same FDA submission
4 devices cleared under K090036, K101409, K102462, K113520, K131078 — 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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