Severity
Moderate
FDA Devices recall · Reported July 1, 2020
Incorrect product labeling.
Argon Medical Devices, Inc recalled BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial Needle MCXS… - a moderate-severity action.
BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial Needle MCXS… was recalled by Argon Medical Devices, Inc in July 1, 2020. Reason: Incorrect product labeling.. Check the official notice for the remedy. Verify recall #Z-2427-2020 with the FDA Devices before acting.
The recall
Argon Medical Devices, Inc issued this moderate-severity FDA Devices recall-Incorrect product labeling..
Sourced from official FDA Devices enforcement records. Verify recall #Z-2427-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2427-2020) was formally reported on July 1, 2020, with the manufacturer initiating the action on December 2, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Argon Medical Devices, Inc is listed as the recalling firm, operating out of Athens, TX. Federal records list the affected scope as 165 units in U.S. and 330 units Internationally.
The documented reason for this recall is: Incorrect product labeling. Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
165 units in U.S. and 330 units Internationally
Related Recalls
6
3 from same agency
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.
Incorrect product labeling.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2427-2020 |
| Date reported | July 1, 2020 |
| Date initiated | December 2, 2019 |
| Recalling firm | Argon Medical Devices, Inc |
| Firm location | Athens, TX |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 1, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.