BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial Needle MCXS1615BP. ...
FDA Device Recall #Z-2427-2020 — Class II — December 2, 2019
Recall Summary
| Recall Number | Z-2427-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 2, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Argon Medical Devices, Inc |
| Location | Athens, TX |
| Product Type | Devices |
| Quantity | 165 units in U.S. and 330 units Internationally |
Product Description
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.
Reason for Recall
Incorrect product labeling.
Distribution Pattern
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 / Code Information
Lot No.: 11277175; Model # 370-1580-01, 16ga x 15cm, for use with Optional Co-axial Needle MCXS1615BP
Other Recalls from Argon Medical Devices, Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0589-2026 | Class II | Option"ELITE Vena Cava Filter System REF 352506... | Sep 12, 2025 |
| Z-3192-2024 | Class II | BioPince Ultra Full Core Biopsy Instrument: REF... | Jul 2, 2024 |
| Z-2638-2024 | Class II | L-CATH PICC S/L Peripherally Inserted Central C... | Jun 14, 2024 |
| Z-2239-2023 | Class II | Argon Medical Devices, REF 352506070E, Option E... | Jun 8, 2023 |
| Z-0563-2022 | Class II | 1. Arterial Line Kit 20ga x 6" 2. Arterial L... | Jan 24, 2022 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.