Stryker SelectCore Variable Throw Biopsy Device — Class II medical device recall Z-2102-2015
Terminated recall by Stryker Instruments Div. of Stryker Corporation, reported 2015-07-29, distributed nationwide. Stryker Instruments is recalling the Stryker SelectCore Variable Throw Biopsy Device due to the potential for
| Recall number | Z-2102-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2015-06-02 |
| Classified | 2015-07-17 |
| Reported by FDA | 2015-07-29 |
| Terminated | 2015-09-03 |
| Distributed | Nationwide (US) |
| Quantity | 55 units |
| Lot numbers | 61406001 |
| Model numbers | 0904-410-000 |
Product
Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM Product Usage: The Stryker SelectCore Variable Throw Biopsy Device is used in obtaining biopsy samples from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes, and various soft tissue tumors. For breast biopsy this product is for diagnosis onlynot therapeutic use.. These devices are sterile, single use devices.
Reason for recall
Stryker Instruments is recalling the Stryker SelectCore Variable Throw Biopsy Device due to the potential for for the stylet to eject from the SelectCore device during actuation.
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-2102-2015. 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.