Spirotome" Soft-Tissue Biopsy Needle Set — Class II medical device recall Z-0124-2015
Terminated recall by Cook Medical Incorporated, reported 2014-11-05, distributed nationwide. MEDINVENTS, the manufacturer of the Spirotome" Soft-Tissue Biopsy Needle Set distributed by Cook Medical,
| Recall number | Z-0124-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Medical Incorporated, Bloomington, IN, United States |
| Recall initiated | 2014-09-26 |
| Classified | 2014-10-24 |
| Reported by FDA | 2014-11-05 |
| Terminated | 2016-02-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | MX |
| Quantity | 1,239 units |
| Lot numbers | P020413A, P020413B, P020413C, P020413D, P020413E, P020413F, P030214A, P030214B, P030214C, P190813B, P190813D, P190813E, P190813F, P300913A, P300913B |
| Model numbers | SS-08-06 |
Product
Spirotome" Soft-Tissue Biopsy Needle Set. The Spirotome Biopsy Needle Set includes a two-part introducer needle that consists of a cutting cannula and a trocar stylet, a helical-tip biopsy needle that has been sized to fit through the lumen of the cutting cannula. The Spirotome Biopsy Needle Set is intended for percutaneous acquisition of soft tissue specimens for laboratory analysis.
Reason for recall
MEDINVENTS, the manufacturer of the Spirotome" Soft-Tissue Biopsy Needle Set distributed by Cook Medical, has initiated a voluntary recall of these products. The recall has been initiated due to customer complaints that the protective caps were dislodged in the pouch. Further investigation disclosed potential dislodging of protective caps on the needle tips on other distributed products.
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-0124-2015. 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.