SharkCore Fine Needle Biopsy System (25GA) recallZ-1474-2017 · Medtronic · initiated Feb 8, 2017
Class II Terminated All recalls posted in February 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Handle may break during use.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-1474-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 8, 2017
- Posted by the FDA
- Feb 28, 2017
- Recalling firm
- Medtronic
- Quantity
- 1,096 Units (total for all products)
- Product code
- FCG
- FDA submissions
- K103668
- 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 description
SharkCore Fine Needle Biopsy System (25GA); Material/Part#: DSC-25-01
Code information (models, lots, serial numbers)
Lot number: B000000174
Other devices under the same FDA submission
3 devices cleared under K103668 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Beacon DSN-22-01Covidien LP · Biopsy needle1 death7 reports
- Beacon DSN-25-01Covidien LP · Biopsy needle1 report
- Beacon N-22-05Covidien LP · Biopsy needle1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 76497).
- Z-1472-2017 · TerminatedBNX Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01
- Z-1473-2017 · TerminatedSharkCore Fine Needle Biopsy System (22 GA); Material/Part #s: DSC-22-01
- Z-1475-2017 · TerminatedSharkCore LG Fine Needle Biopsy System (19GA); Material/Part#: DSL-19-01
- Z-1476-2017 · TerminatedBNX Fine Need Aspiration System (22GA); Material/Part#: DSN-22-01
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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