Advanced Sterilization Products Recalls STERRAD Sterilization Systems
Advanced Sterilization Products is recalling STERRAD NX and 100NX sterilizers because bronchoscopes may contain unlisted polyurethane material in the suction channel.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 a material not listed in the device's claims, which is a labeling or specification issue. No illnesses, injuries, or deaths are reported in the source text, 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 devices are low-temperature general-purpose sterilizers used to process 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. This specific material is not listed in the current claims for interior channels (lumens) for processing in STERRAD systems.
The recall involves a total of 4,381 units that were distributed nationwide. The source text does not specify the exact actions consumers or healthcare facilities should take, nor does it report any illnesses or injuries associated with this recall.
The recalled product
- Product
- STERRAD 100NX, Product Code: 10104 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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