CLASS II Device recall · Reported 1 Jul 2020 · FDA Enforcement Report

BioPince Full Core Biopsy Instrument.,Use recalled

Argon Medical Devices is recalling BioPince Full Core Biopsy Instrument.,Use with Optional CO-Axial Needle MCXS1615BP, distributed nationwide in the US. The recall was initiated on 2 Dec 2019 and the FDA has classified it as Class II.

Check your package

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

Quantity recalled165 units in U.S. and 330 units Internationally

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2427-2020
FDA event ID: 85426
Recalling firm: Argon Medical Devices, Athens, TX
Classification: Class II
Status: Terminated
Recall initiated: 2 Dec 2019
FDA classified: 25 Jun 2020
Reported: 1 Jul 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Syringes & Needles

Timeline

2 Dec 2019	Recall initiated by company
25 Jun 2020	Classified by FDA	+206 days
1 Jul 2020	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Incorrect product labeling.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide California Florida Illinois Kansas Maryland New York Pennsylvania Texas Washington Wisconsin

Questions about this recall

Why was it recalled?

Incorrect product labeling.

Which lots are affected?

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

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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