Advanced Sterilization Products Recalls STERRAD NX Sterilization Systems
Advanced Sterilization Products is recalling STERRAD NX and STERRAD 100NX sterilization systems because bronchoscopes may contain unlisted polyurethane material in the suction channel.
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 illnesses, injuries, or hospitalizations. The hazard is a material compatibility issue (unlisted polyurethane) rather than a direct biological or physical threat, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization systems. These are low-temperature general-purpose sterilizers used to sterilize heat and moisture-sensitive reusable medical devices.
The recall was initiated because ASP determined that bronchoscopes may contain a polyurethane material in the suction channel location that is not listed in the current claims for interior channels (lumens) for processing in STERRAD systems. This discrepancy means the device may not be compatible with the specific materials present in the bronchoscopes being processed.
A total of 4,381 units were distributed nationwide. The source text does not specify specific dates of distribution or identify specific facilities affected beyond the nationwide distribution pattern. Users of these systems should contact Advanced Sterilization Products for further instructions on how to proceed.
The recalled product
- Product
- STERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
- Manufacturer
- Advanced Sterilization Products
- Affected units
- 4,381
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)
- Please refer to consignee list
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
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