Steris Corporation: Medical Device Recall in 2012 - (Recall #: Z-2335-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: August 1, 2012

Date Posted: September 19, 2012

Recall Number: Z-2335-2012

Event ID: 62895

Reason for Recall:

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.

Status: Terminated

Product Quantity: 6,051 units

Code Information:

Model #: P6500, S/N 400000 through 406294

Distribution Pattern:

Worldwide Distribution -- USA (nationwide) and the countries of Bahrain and Hong Kong.

Voluntary or Mandated:

Voluntary: Firm initiated