StoneBreaker Single Use Probe — Class II medical device recall Z-1596-2018
Terminated recall by Cook Inc., reported 2018-05-09, distributed nationwide. The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following
| Recall number | Z-1596-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Inc., Bloomington, IN, United States |
| Recall initiated | 2018-01-31 |
| Classified | 2018-05-02 |
| Reported by FDA | 2018-05-09 |
| Terminated | 2020-04-17 |
| Distributed | Nationwide (US) |
| Quantity | 12,556 |
| Reason classes | sterility |
| Model numbers | SBP-010500 |
Product
StoneBreaker Single Use Probe, Catalog numbers: SBP-010500; SBP-010605; SBP-016500; SBP-016605; SBP-020425 GPN : G52607; G52605; G52606; G52609; G52608
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1596-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.