Advanced Sterilization Products Recalls STERRAD Sterilization Systems Due to Odors
Advanced Sterilization Products is recalling STERRAD NX, 50, and 100S sterilization systems because healthcare workers detected odors possibly emanating from the devices.
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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is limited to detected odors, which fits the criteria for a moderate severity recall involving potential but unconfirmed risks.
Plain-English summary
Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems. These devices are general purpose, low temperature sterilizers used to inactivate microorganisms on a broad range of medical devices and surgical instruments.
The recall was initiated because some healthcare workers detected odors or smells possibly emanating from the STERRAD Systems. The source text does not specify the nature of the odors, the number of units affected, or any reported injuries or illnesses.
Healthcare facilities using these sterilization systems should contact Advanced Sterilization Products for further instructions on how to proceed with the recall.
The recalled product
- Product
- STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD NX process to inactivate microorganisms on a broad range of medical devices and surgical instruments.
- Manufacturer
- Advanced Sterilization Products
- Hazard
- Affected units
- 5,584
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- not available
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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 3 products in this recall →Related recalls
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