Data Foundry

Medical device recalls 2013

Sterrad 100NX — Class II medical device recall Z-0190-2014

Terminated recall by Advanced Sterilization Products, reported 2013-11-20, distributed nationwide. Advanced Sterilization Products (ASP) is recalling the Sterrad 100NX Sterilizer some healthcare workers detect

Recall numberZ-0190-2014
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmAdvanced Sterilization Products, Irvine, CA, United States
Recall initiated2013-10-18
Classified2013-11-08
Reported by FDA2013-11-20
Terminated2014-01-16
DistributedNationwide (US)
Countries outside the USCA, JP
Lot numbers100000179, 100000198, 100002674, 100003504, 100003630, 100003638, 100006921, 100007650, 100009087, 100009190, 100014663, 100015438, 100017950, 100018296, 100018696, 100025373, 100025483, 100026525, 100026969, 100027146, 100027229, 100029273, 100048656, 100048894, 100063107, 100065032, 100066627, 100068933, 100069191, 100071554, 100073648, 100073851, 100075132, 100094058, 100094223, 100096391, 100097448, 100097463, 100097582, 100098349 and 460 more

Product

Sterrad 100NX, Product Code: 10104. Used to sterilize heat and moisture sensitive reusable medical devices.

Reason for recall

Advanced Sterilization Products (ASP) is recalling the Sterrad 100NX Sterilizer some healthcare workers detected odors/smells emanating from the 100NX Sterilizers, and it may be related to normal breakdown of the oil used in the Sterrad 200 vacuum pumps.

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-0190-2014. 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.