Data Foundry

Medical device recalls 2015

Wall Chart for STERRAD 100NX System — Class II medical device recall Z-2375-2015

Terminated recall by Advanced Sterilization Products, reported 2015-08-19, distributed nationwide. Advanced Sterilization PRoducts (ASP) is recalling the Wall Chart for STERRAD 100NX System because it incorrec

Recall numberZ-2375-2015
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmAdvanced Sterilization Products, Irvine, CA, United States
Recall initiated2015-07-17
Classified2015-08-13
Reported by FDA2015-08-19
Terminated2016-05-20
DistributedNationwide (US)
Quantity1,465 units
Reason classeschemical contamination
UPC / GTIN / UDI-DI10104001070004, 10104001070042, 10104001070059, 10104001080027, 10104001080034, 10104001080041, 10104001080058, 10104001080065, 10104001080072, 10104002070034

Product

Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures.

Reason for recall

Advanced Sterilization PRoducts (ASP) is recalling the Wall Chart for STERRAD 100NX System because it incorrectly states "APTIMAX Instrument Trays can be enclosed in either polypropylene wrap or in Tyvek Pouches with STERRAD Chemical Indicators."

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-2375-2015. 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.