AMSCO 400 and AMSCO C Small Steam Sterilizers — Class III medical device recall Z-0210-2016
Terminated recall by Steris Corporation, reported 2015-11-11, distributed nationwide. In AMSCO Small Steam Sterilizers equipped with the CS-iQ feature, the sterilizer software inadvertently preven
| Recall number | Z-0210-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Steris Corporation, Mentor, OH, United States |
| Recall initiated | 2015-09-03 |
| Classified | 2015-11-04 |
| Reported by FDA | 2015-11-11 |
| Terminated | 2016-01-22 |
| Distributed | Nationwide (US) |
| Quantity | 32 units |
| Reason classes | software |
| Serial numbers | 030341514, 030501540, 030621412, 030651519, 030741306, 030871410, 030871412, 031491314, 031751401, 031771425, 031781412, 031781414, 031911436, 032341304, 032381302, 033281222, 033331205, 033341248, 033351210, 033401221, 033411215, 033451217, R020141502, R020151501, R020191502 and 7 more |
Product
AMSCO 400 and AMSCO C Small Steam Sterilizers
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0210-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.