AMSCO C and AMSCO 400 Steam Sterilizers — Class II medical device recall Z-1561-2015

Terminated recall by Steris Corporation, reported 2015-05-06, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. STERIS has identified that the control board software in select AMSCO 400 and AMSCO C units will interrupt and

Recall number	`Z-1561-2015`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Steris Corporation, Mentor, OH, United States
Recall initiated	2015-02-19
Classified	2015-04-30
Reported by FDA	2015-05-06
Terminated	2016-01-20
Distributed	AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY
Countries outside the US	AE, AF, CA, JP, KR, KW, MX
Quantity	701 units
Reason classes	software
Serial numbers	`030051501`, `033641440`, `R020051501`, `R023641403`

Product

AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation. AMSCO C Small Sterilizer, AMSCO 400 Small Sterilizer, AMSCO 400 Medium Sterilizer. Designed for sterilization of heat and moisture-stable materials used in healthcare facilities.

Reason for recall

STERIS has identified that the control board software in select AMSCO 400 and AMSCO C units will interrupt and cancel a processing cycle should the selected sterilizer shutdown time coincide with a processing cycle. This may result in a procedure delay.

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-1561-2015. 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.