Cook Inc. Recalls StoneBreaker Exhaust Lines Due to Sterility Concerns
Cook Inc. is recalling 760 StoneBreaker Exhaust Lines because the interior may not be properly sterilized during reprocessing.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (inadequate sterilization) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Cook Inc. is recalling 760 units of the StoneBreaker Exhaust Line (Catalog number: SBA-EL; GPN: G52600). The recall was initiated because the interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions provided in the Instructions for Use.
The affected products were distributed nationwide in the United States and in numerous countries internationally, including Canada, Australia, and various nations in Europe, Asia, and South America. The recall covers all lots of the product.
Healthcare providers and facilities should stop using the affected StoneBreaker Exhaust Lines and contact Cook Inc. for further instructions on how to return or dispose of the products.
The recalled product
- Product
- StoneBreaker Exhaust Line, Catalog number: SBA-EL; GPN: G52600; UDI: (01)00827002526006
- Manufacturer
- Cook Inc.
- Affected units
- 760
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)
- All Lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Cook Inc. 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.
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