Steris Corporation: Medical Device Recall in 2015 - (Recall #: Z-0210-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

AMSCO 400 and AMSCO C Small Steam Sterilizers

Product Classification:

Class III

Date Initiated: September 3, 2015

Date Posted: November 11, 2015

Recall Number: Z-0210-2016

Event ID: 72217

Reason for Recall:

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.

Status: Terminated

Product Quantity: 32 units

Code Information:

Serial #'s: 033331205, 033341248, 033351210, 033401221, 033411215, 033451217, 030741306, 031491314, 032381302, 032341304, 033281222, 030621412, 030871412, 030871410, 031751401, 031771425, 031781412, 031781414, 031911436, R020141502, R020151501, R020191502, R020201501, R020261502, R020261504, R020271501, 030341514, R020471501, 030501540, 030651519, R021001503, R021051501

Distribution Pattern:

US nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated