Steris Corporation recalls AMSCO 400 and AMSCO C Small Steam Sterilizers

Recall date

September 3, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0210-2016

FDA classification

Class III

Brand / firm

Steris Corporation

Sold / distributed

US nationwide distribution.

Why it was recalled

In AMSCO Small Steam Sterilizers equipped with the CS-iQ feature, the sterilizer software inadvertently prevents the capability to operate the foot pedal, which allows the Operator to open and close the sterilizer door.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

AMSCO 400 and AMSCO C Small Steam Sterilizers