FDA Medical Device Recalls (openFDA)
Steris Corporation: 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.
- Recall number
- Z-2335-2012
- Recalling firm
- Steris Corporation
- 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.
- Status
- Terminated
- Initiated
- 2012-08-01
- Posted
- 2012-09-07
- Terminated
- 2014-06-06
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 6,051 units
- Distribution
- Worldwide Distribution -- USA (nationwide) and the countries of Bahrain and Hong Kong.
- Lot, serial or model codes
- Model #: P6500, S/N 400000 through 406294
- 510(k) numbers
- ["K090036","K101409","K102462"]
- PMA numbers
- not on file
- Product code
- MED
- Firm FEI
- 1527821
- Firm city
- Mentor
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28