SharkCore Fine Needle Biopsy System — Class II medical device recall Z-1473-2017
Terminated recall by Medtronic, reported 2017-03-22, distributed in AL, AR, AZ, CA, CO, CT, DC, DE…. Handle may break during use.
| Recall number | Z-1473-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic, North Haven, CT, United States |
| Recall initiated | 2017-02-08 |
| Classified | 2017-03-15 |
| Reported by FDA | 2017-03-22 |
| Terminated | 2019-07-18 |
| Distributed | AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI |
| Quantity | 1,096 units |
| Reason classes | device malfunction |
| Lot numbers | B000000164, B000000170, B000000173, B000000178 |
| Model numbers | DSC-22-01 |
Product
SharkCore Fine Needle Biopsy System (22 GA); Material/Part #s: DSC-22-01
Reason for recall
Handle may break during 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-1473-2017. 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.