AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of… — Class II medical device recall Z-0915-2013
Terminated recall by Steris Corporation, reported 2013-03-13, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. The control boards alarm set points and temperature tolerances allowed for erroneous activation of the AD (an
| Recall number | Z-0915-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Steris Corporation, Mentor, OH, United States |
| Recall initiated | 2013-02-12 |
| Classified | 2013-03-06 |
| Reported by FDA | 2013-03-13 |
| Terminated | 2013-12-05 |
| Distributed | 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, TN, TX, UT, VA, VT, WA, WI, WV |
| Countries outside the US | CA |
| Quantity | 395 units |
| Serial numbers | 021911201, 023461202, 030181215-030291310 |
Product
AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities.
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.
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-0915-2013. 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.