Z-0915-2013Class II

AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used...

Name: Z-0915-2013 AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used...
Creator: Steris Corporation
Published: 2013-02-12
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2013-02-12 / Terminated / root cause: software

FDA source

Steris Corporation began a recall of AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities on 2013-02-12. FDA classified it as Class II and gives the reason as "The control boards alarm set points and temperature tolerances allowed for erroneous activation of the AD (analog/digital) alarm as temperature fluctuated during operation. When this alarm occurs, the sterilizer locks...". 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-0915-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-12
Posted: 2013-03-06
Terminated: 2013-12-05
Recalling firm: STERIS Corporation
Product: AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities.
Product code: FLE Sterilizer, Steam
Reason for recall: The control boards alarm set points and temperature tolerances allowed for erroneous activation of the AD (analog/digital) alarm as temperature fluctuated during operation. When this alarm occurs, the sterilizer locks up and cannot be used until serviced, causing Customer nuisance.
Root cause tag: software
FDA root cause: Software design
Action: Steris Corporation initiated their recall on February 12, 2013. They will notify customers via onsite visits by STERIS Field Service Technicians to each affected Customer site. For further questions, please call (440) 392-7601.
Quantity in commerce: 395 Units
Distribution: Worldwide Distribution - USA including Canada and the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, SK, TN, TX, UT, VA, VT, WA, WI, and WV.
Product codes and lots: AMSCO C: Serial Numbers: 021911201 023461202 AMSCO 400: Serial Numbers: 030181215-030291310

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0915-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0915-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-13	2013-03-06

Product code FLE

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)