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

Recall Insight

This FDA Devices action (record #Z-0190-2014) was formally reported on November 20, 2013, with the manufacturer initiating the action on October 18, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Advanced Sterilization Products is listed as the recalling firm, operating out of Irvine, CA. Federal records indicate 2106 units total (1224 units in US) units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: 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 us… Distribution data in the federal record shows the product reached: Worldwide Distribution-USA (nationwide) and the countries of EMEA, APAC, Japan, Canada. AE, AU, BE, BH, CA, CH, CL, CN, CO, DE, EC, ES, GB, GR, HK, HU, IL, IN, IT, JP, KR, KW, MX, MY, NX, PA, PH, PK, PL, PR, QA, RU, SA…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 13 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.