Steris Corporation: Medical Device Recall in 2019 - (Recall #: Z-0995-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

AMSCO 3000 Series Washer/Disinfector Model # 3052

Product Classification:

Class II

Date Initiated: December 20, 2018

Date Posted: March 20, 2019

Recall Number: Z-0995-2019

Event ID: 82035

Reason for Recall:

The software in the systems may not process the cycle originally intended. This could result in damage to the various medical devices and instruments processed in the washer/disinfector or potential for inadequate cleaning or disinfection.

Status: Terminated

Product Quantity: 11

Code Information:

Serial Numbers 3602014006 3631618006 3628818009 3629518008 3633018010 3626718010 3630918008 3630918010 3617717013 3620016019 3623516006

Distribution Pattern:

The products were distributed to the following US states: AL, AR, CA, CO, FL, GA, IL, LA, MA, MD, ME, MI, NC, NJ, NM, NY, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. The products were distributed to the following foreign countries: Bahrain, Brazil, Canada, China, Saudi Arabia, South Korea, and Taiwan.

Voluntary or Mandated:

Voluntary: Firm initiated