FDA Device recall Z-1475-2017
SharkCore LG Fine Needle Biopsy System (19GA)
- FDA Device
- Class II
- terminated
- Published 2017-03-22
On 2017-03-22 the FDA classified a Class II recall of SharkCore LG Fine Needle Biopsy System (19GA) by Medtronic, citing handle may break during use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1475-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-02-08 |
| Published | 2017-03-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic |
| Distribution | 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 |
Product
SharkCore LG Fine Needle Biopsy System (19GA); Material/Part#: DSL-19-01
Reason
Handle may break during use.
Identifiers
| code_info | Lot number: B000000166 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1475-2017%22
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