Data Foundry

Medical device recalls 2019

AMSCO 3000 Series Washer/Disinfector Model # 3052 — Class II medical device recall Z-0995-2019

Terminated recall by Steris Corporation, reported 2019-03-20, distributed in AL, AR, CA, CO, FL, GA, IL, LA…. The software in the systems may not process the cycle originally intended. This could result in damage to the

Recall numberZ-0995-2019
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmSteris Corporation, Mentor, OH, United States
Recall initiated2018-12-20
Classified2019-03-08
Reported by FDA2019-03-20
Terminated2019-07-22
DistributedAL, AR, CA, CO, FL, GA, IL, LA, MA, MD, ME, MI, NC, NJ, NM, NY, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV
Countries outside the USBH, BR, CA, CN, KR, SA, TW
Quantity11
Reason classessoftware
Serial numbers3602014006, 3617717013, 3620016019, 3623516006, 3626718010, 3628818009, 3629518008, 3630918008, 3630918010, 3631618006, 3633018010
Model numbers3052

Product

AMSCO 3000 Series Washer/Disinfector Model # 3052

Reason for recall

The software in the systems may not process the cycle originally intended. This could result in damage to the various medical devices and instruments processed in the washer/disinfector or potential for inadequate cleaning or disinfection.

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-0995-2019. 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.