Z-0210-2016Class III

AMSCO 400 and AMSCO C Small Steam Sterilizers

Name: Z-0210-2016 AMSCO 400 and AMSCO C Small Steam Sterilizers
Creator: Steris Corporation
Published: 2015-09-03
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2015-09-03 / Terminated / root cause: software

FDA source

Steris Corporation began a recall of AMSCO 400 and AMSCO C Small Steam Sterilizers on 2015-09-03. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0210-2016
Classification: Class III
Status: Terminated
Initiated: 2015-09-03
Posted: 2015-11-04
Terminated: 2016-01-22
Recalling firm: STERIS Corporation
Product: AMSCO 400 and AMSCO C Small Steam Sterilizers
Product code: FLE Sterilizer, Steam
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.
Root cause tag: software
FDA root cause: Software design
Action: On 9/21/2015 the firm sent Recall Correction Notices to their customers.
Quantity in commerce: 32 units
Distribution: US nationwide distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0210-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0210-2016	Class III	Terminated	Voluntary: Firm initiated	2015-11-11	2015-11-04

Product code FLE

K111223Class IIAmsco Chimeron Small Steam SterilizerSTERIS Corporation / cleared 2011-09-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)