Z-1475-2017Class II

SharkCore LG Fine Needle Biopsy System (19GA); Material/Part#: DSL-19-01

Name: Z-1475-2017 SharkCore LG Fine Needle Biopsy System (19GA); Material/Part#: DSL-19-01
Creator: Medtronic
Published: 2017-02-08
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2017-02-08 / Terminated / root cause: manufacturing process

FDA source

Medtronic began a recall of SharkCore LG Fine Needle Biopsy System (19GA); Material/Part#: DSL-19-01 on 2017-02-08. FDA classified it as Class II and gives the reason as "Handle may break during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1475-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-08
Posted: 2017-02-28
Terminated: 2019-07-18
Recalling firm: Medtronic, Inc.
Product: SharkCore LG Fine Needle Biopsy System (19GA); Material/Part#: DSL-19-01
Product code: FCG Biopsy Needle
Reason for recall: Handle may break during use.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: A recall was initiated on February 8, 2017. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 1856 Corporate Dr. Suite 140 Norcross, GA 30093, Attention: Field Returns Department. Disposition of product within Medtronic control and customer returned devices: Will be reworked.
Quantity in commerce: 1,096 Units (total for all products)
Distribution: US Distribution to 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; and countries of DK and DE
Product codes and lots: Lot number: B000000166

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1475-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1472-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-22	2017-03-15
Z-1473-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-22	2017-03-15
Z-1474-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-22	2017-03-15
Z-1475-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-22	2017-03-15
Z-1476-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-22	2017-03-15

Product code FCG

K103668Class IIBnx Fine Needle Aspiration SystemBoston Endoscopic Engineering / cleared 2010-12-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)