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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85426

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 02, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Argon Medical Devices, Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2427-2020
Recall number
Z-2427-2020
Initiated
December 02, 2019
Classification
Class II
Status
Terminated
Quantity
165 units in U.S. and 330 units Internationally

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Incorrect product labeling

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incorrect product labeling.

Code information

Lot No.: 11277175; Model # 370-1580-01, 16ga x 15cm, for use with Optional Co-axial Needle MCXS1615BP

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.

Field note

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