AMSCO C and AMSCO 400 Steam Sterilizers designed for… recallZ-0915-2013 · Steris Corporation · initiated Feb 12, 2013
Class II Terminated All recalls posted in March 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Steris Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-0915-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 12, 2013
- Posted by the FDA
- Mar 6, 2013
- Recalling firm
- Steris Corporation
- Quantity
- 395 Units
- Product code
- FLE
- FDA submissions
- K111223, K112403
- 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 description
AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities.
Code information (models, lots, serial numbers)
AMSCO C: Serial Numbers: 021911201 023461202 AMSCO 400: Serial Numbers: 030181215-030291310
Other devices under the same FDA submission
27 devices cleared under K111223, K112403 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- AMSCO AMSCO 400 Steam SterilizerSteris Mexico, S. de R.L. de C.V. · Sterilizer, steam11 reports
- AMSCO AMSCO 400 Steam SterilizerSteris Mexico, S. de R.L. de C.V. · Sterilizer, steam9 reports
- AMSCO AMSCO 400 Steam SterilizerSteris Mexico, S. de R.L. de C.V. · Sterilizer, steam7 reports
- AMSCO 16CSteris Mexico, S. de R.L. de C.V. · Sterilizer, steam6 reports
- AMSCO AMSCO 400 Steam SterilizerSteris Mexico, S. de R.L. de C.V. · Sterilizer, steam6 reports
- AMSCO AMSCO 400 Steam SterilizerSteris Mexico, S. de R.L. de C.V. · Sterilizer, steam5 reports
- AMSCO AMSCO 400 Steam SterilizerSteris Mexico, S. de R.L. de C.V. · Sterilizer, steam3 reports
- AMSCO AMSCO 400 Steam SterilizerSteris Mexico, S. de R.L. de C.V. · Sterilizer, steam3 reports
- AMSCO AMSCO 400 Steam SterilizerSteris Mexico, S. de R.L. de C.V. · Sterilizer, steam3 reports
- AMSCO 20CSteris Mexico, S. de R.L. de C.V. · Sterilizer, steam2 reports
- AMSCO AMSCO 400 Steam SterilizerSteris Mexico, S. de R.L. de C.V. · Sterilizer, steam2 reports
- AMSCO AMSCO 400 Steam SterilizerSteris Mexico, S. de R.L. de C.V. · Sterilizer, steam2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page