FDA Medical Device Recalls (openFDA)
Argon Medical Devices, Inc: BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial Needle MCXS1615BP. QTY.: 5/CS - Product Usage: The disposable, automatic BioPince Full Core Biopsy Instrument is used to obtain multiple core samples from soft tissue such as liver, kidney, abdominal masses, etc.
- Recall number
- Z-2427-2020
- Recalling firm
- Argon Medical Devices, Inc
- Product
- BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial Needle MCXS1615BP. QTY.: 5/CS - Product Usage: The disposable, automatic BioPince Full Core Biopsy Instrument is used to obtain multiple core samples from soft tissue such as liver, kidney, abdominal masses, etc.
- Status
- Terminated
- Initiated
- 2019-12-02
- Posted
- not on file
- Terminated
- 2022-11-09
- Reason
- Incorrect product labeling.
- Root cause
- Labeling Change Control
- Action
- On December 2, 2019, the firm sent out a "NOTIFICATION OF RECALL" to customers via registered mail, informing customers of the wrong/incorrect, label on the device. The firm requested to their customers to complete the recall form and return it to the firm with the packaged, unused devices. Customers were instructed to inspect, quarantine and return any affected product remaining at their facility utilizing the instruction on the "Recall Response Form". Customers were also instructed to complete the response acknowledgement form included with the letter and return by fax, mail or email as soon as possible to the firm at address provided and to the attention of : Ms. Amy Clendening-Wheeler, RA Manager, email: Amy.Wheeler@argonmedical.com; or Public Contact Information, Rebecca Ellis, VP, RA/QA, Argon Medical Devices 1-469-731-1410 Beckie.Ellis@argonmedical.com Customers were instructed to pass the notice on to all those who need to be aware within their organization or to any organization to which the potentially affected devices have been transferred. For those products in global distribution, Argon to contact the relevant foreign regulatory bodies and conduct similar notifications of foreign distributors on a country by country basis. Returned goods to be reworked with correct labeling. Rework instruction/procedure has been requested by FDA.
- Quantity
- 165 units in U.S. and 330 units Internationally
- Distribution
- Worldwide distribution - US Nationwide including in the states of TX, IL, FL, KS, MD, CA, WA, NY, WI, PA and the countries of United Arab Emirates (Dubai), Spain, Canada.
- Lot, serial or model codes
- Lot No.: 11277175; Model # 370-1580-01, 16ga x 15cm, for use with Optional Co-axial Needle MCXS1615BP
- 510(k) numbers
- ["K904987"]
- PMA numbers
- not on file
- Product code
- KNW
- Firm FEI
- 1625425
- Firm city
- Athens
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28