Advanced Sterilization Products Recalls STERRAD 100NX Sterilization Systems
Advanced Sterilization Products is recalling STERRAD 100NX Sterilization Systems because they may emit unusual odors into the surrounding environment.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves unusual odors without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Advanced Sterilization Products (ASP) is recalling 1,500 units of the STERRAD 100NX Sterilization System, Product Number 10104. The product is a general-purpose, low-temperature sterilizer used to inactivate microorganisms on medical devices and surgical instruments. The recall was initiated because ASP determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems may emit an odor or smell into the surrounding environment that is not typical of normal operating conditions.
The affected units were distributed nationwide in the United States. The recall covers specific Service Order (SO) numbers listed in the agency's official documentation. No specific illnesses, injuries, or deaths are reported in the source text.
Consumers and healthcare facilities should check their inventory for the STERRAD 100NX Sterilization System with Product Number 10104 and verify if their unit's Service Order number matches the list provided by the FDA. If a unit is affected, users should contact Advanced Sterilization Products for instructions on how to proceed with the recall.
The recalled product
- Product
- STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.
- Manufacturer
- Advanced Sterilization Products
- Hazard
- Affected units
- 1,500
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Advanced Sterilization Products under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Advanced Sterilization Products
See all →- HighAdvanced Sterilization Products Recalls STERRAD NX Sterilization Systems
FDA (Devices) · 2017-02-22
- ModerateASP Recalls EVOTECH Endoscope Cleaner Due to Hose Leak Risk
FDA (Devices) · 2017-01-18
- ModerateAdvanced Sterilization Products Recalls CIDEX OPA Solution for Rinsing Labeling
FDA (Devices) · 2015-09-23
- ModerateAdvanced Sterilization Products Recalls CIDEX Activated Dialdehyde Solution
FDA (Devices) · 2015-09-02
- ModerateAdvanced Sterilization Products Recalls STERRAD 100NX Wall Charts for Incorrect Instructions
FDA (Devices) · 2015-08-19
Same hazard · unusual odor
See all →- ModerateLegacy Pharmaceutical Packaging Recalls Fluoxetine Capsules Due to Odor Complaints
FDA (Drugs) · 2014-05-07
- ModerateAdvanced Sterilization Products Recalls STERRAD 200 Sterilization Systems
FDA (Devices) · 2013-04-10