FDA Medical Device Recalls (openFDA)
Steris Corporation: AMSCO 3000 Series Washer/Disinfector Model # 3052
- Recall number
- Z-0995-2019
- Recalling firm
- Steris Corporation
- Product
- AMSCO 3000 Series Washer/Disinfector Model # 3052
- Status
- Terminated
- Initiated
- 2018-12-20
- Posted
- not on file
- Terminated
- 2019-07-22
- Reason
- 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.
- Root cause
- Software Manufacturing/Software Deployment
- Action
- Urgent Device Field Correction notification letters dated 12/20/18 were sent to customers.
- Quantity
- 11
- Distribution
- 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.
- Lot, serial or model codes
- Serial Numbers 3602014006 3631618006 3628818009 3629518008 3633018010 3626718010 3630918008 3630918010 3617717013 3620016019 3623516006
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MEC
- 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