FDA Medical Device Recalls (openFDA)
Steris Corporation: AMSCO 400 and AMSCO C Small Steam Sterilizers
- Recall number
- Z-0210-2016
- Recalling firm
- Steris Corporation
- Product
- AMSCO 400 and AMSCO C Small Steam Sterilizers
- Status
- Terminated
- Initiated
- 2015-09-03
- Posted
- 2015-11-04
- Terminated
- 2016-01-22
- Reason
- 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.
- Root cause
- Software design
- Action
- On 9/21/2015 the firm sent Recall Correction Notices to their customers.
- Quantity
- 32 units
- Distribution
- US nationwide distribution.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K111223"]
- PMA numbers
- not on file
- Product code
- FLE
- 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