Advanced Sterilization Products Recalls STERRAD Sterilization Systems Due to Odor Reports
Advanced Sterilization Products is recalling STERRAD 50, NX, 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. The hazard involves detected odors without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
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 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 specific cause, or any reported injuries or illnesses.
The recall involves 233 units of the STERRAD 50 Sterilization System, which were distributed nationwide. The source text does not provide specific lot numbers or additional distribution details for the other models mentioned.
The recalled product
- Product
- STERRAD 50 Sterilization System, Product Code: 10050 The STERRAD 50 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 50 process to inactivate microorganisms on a broad range of medical devices and surgical instruments.
- Manufacturer
- Advanced Sterilization Products
- Hazard
- Affected units
- 233
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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