Cook Inc. Recalls StoneBreaker Single Use Probes for Sterility Concerns
Cook Inc. is recalling 12,556 StoneBreaker Single Use Probes because the interior may not be properly sterilized. The recall covers units distributed in the US and 70 other countries.
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, which indicates a risk of temporary or medically reversible adverse health consequences. The hazard involves potential lack of sterilization, which is a significant risk-of-harm product issue where injury has not yet been reported.
Plain-English summary
Cook Inc. is recalling 12,556 units of the StoneBreaker Single Use Probe. The affected catalog numbers are SBP-010500, SBP-010605, SBP-016500, SBP-016605, and SBP-020425. The recall includes all lots of these products.
The recall was issued because the interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use. This is an FDA Class II recall, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
The affected products were distributed nationwide in the United States and in 70 other countries, including Canada, the United Kingdom, Germany, and Australia. Healthcare providers and facilities should stop using these probes and contact Cook Inc. for further instructions.
The recalled product
- Product
- StoneBreaker Single Use Probe, Catalog numbers: SBP-010500; SBP-010605; SBP-016500; SBP-016605; SBP-020425 GPN : G52607; G52605; G52606; G52609; G52608
- Manufacturer
- Cook Inc.
- Affected units
- 12,556
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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