Cook Inc. Recalls StoneBreaker Pneumatic Lithotripter Due to Sterility Concerns
Cook Inc. is recalling 751 units of the StoneBreaker Pneumatic Lithotripter because the device 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 involves a medical device with a potential sterility failure, which poses a risk of infection (harm) to patients, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cook Inc. is recalling 751 units of the StoneBreaker Pneumatic Lithotripter (Catalog number: SBL-KIT1; GPN: G52604). 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 devices were distributed nationwide in the United States and in numerous countries internationally, including Australia, Canada, China, Germany, India, and the United Kingdom. The recall applies to all lots of the product.
Healthcare providers and facilities should stop using the affected devices and contact Cook Inc. for further instructions on reprocessing or replacement. Patients who have had the device used on them should consult their healthcare provider if they have concerns about potential infection risks.
The recalled product
- Product
- StoneBreaker Pneumatic Lithotripter, Catalog number: SBL-KIT1; GPN: G52604 UDI:(01)00827002526044
- Manufacturer
- Cook Inc.
- Affected units
- 751
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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