BioPince Ultra Full Core Biopsy Instrument: REF: REF:… recallZ-3192-2024 · Argon Medical Devices, Inc · initiated Jul 2, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Argon Medical Devices, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier, which may lead to cross contamination, or the introduction of micro-organisms into the access site, which could lead to an infectious process, bacteremia, or sepsis.
FDA root cause category: Packaging change control
What the company is doing
On 7/2/24, recall notices were mailed and emailed to Physician, Clinician, or Hospital Administrators who were asked to do the following: 1) Discontinue use of affected devices. 2) Segregate, quarantine, and return affected devices to the recalling firm. 3) Share this recall notice with the following parties to ensure your consignees receive a copy of this notice and the associated response form: a. Anyone who needs to be aware within your organization b. Any organization where the potentially affected products have been transferred or further distributed c. Anyone within your organization who may use this device 4) Complete and return the response form via email to [email protected]
Recall details
- Recall number
- Z-3192-2024
- Status
- Open, Classified
- Initiated by the company
- Jul 2, 2024
- Posted by the FDA
- Sep 20, 2024
- Recalling firm
- Argon Medical Devices, Inc
- Quantity
- 95,430
- Product code
- KNW
- FDA submissions
- K904987, K982960
- Distribution
- Worldwide - US Nationwide distribution including in the states of AZ, FL, OH, NY, MO, CO, IL, NC, CA, AK, PA, MN, ND, TX, SC, AR, WI, OK, TN, KS, UT, NJ, VA, MA, KY, IN, AL, DE, MT, NE, WV, NV, HI, OR, WA, NH, LA, CT, MI, GA, MD, ID, MS, IA, RI, NM, VT and the countries of ITA, TUN, ROU, LTU, BEL, GBR, CAN, TUR, POL, PAN, THA, PRT, TWN, AUT, NZL, AUS, BGR, MEX, CHE, NLD, PHL, PER, FRA, SGP, ZAF, CZE, EST, ESP, OMN, NPL, COL, PRI, ISR, JPN, KEN, BHR, ARE, CHN.
Product description
BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02, 360-1580-03, 360-2080-01, 360-2080-02, 360-2080-03, 370-1080-01, 370-1080-02, 370-1080-03, 370-1580-01, 370-1580-02, 370-1580-03; Tru-Core II Biopsy Instrument, REF: 763114100x, 763116100X, 763116160X, 763118100X, 763118200X, 763120100X, 763120160X, 763418200X, 763418250X, 763114200X
Code information (models, lots, serial numbers)
Show the full code information (3k characters)
REF/Box UDI-DI/Unit UDI-DI/Lot(Expiration Date): 360-1080-01/20886333004373/00886333004379/11563436(22-Mar-2027), 11568010(16-Apr-2027), 11568790(1-May-2027), 11569552(7-May-2027), 11572560(20-May-2027) 360-1080-02/20886333224009/00886333224005/11563678(22-Mar-27), 11562475(05-Mar-27), 11562476(14-Mar-27), 11566932(08-Apr-27), 11567139(11-Apr-27), 11568361(16-Apr-27), 11569013(23-Apr-27), 11569844(29-Apr-27), 11571094(02-May-27), 11572044(08-May-27), 11572886(26-May-27); 360-1080-03/20886333224016/00886333224012/11569845(22-Apr-27), 11562477(04-Mar-27), 11564861(26-Mar-27), 11567888(12-Apr-27), 11568554(18-Apr-27), 11570075(04-May-27); 360-1580-01/20886333004359/00886333004355/11563438(21-Mar-2027), 11563439(19-Mar-2027); 360-1580-02/20886333224023/00886333224029/11562478(14-Mar-27), 11563440(18-Mar-27), 11563682(20-Mar-27), 11565238(03-Apr-27), 11566882(09-Apr-27), 11570132(01-May-27), 11570814(09-May-27), 11573339(20-May-27); 360-1580-03/20886333224030/00886333224036/11570288(02-May-27), 11563442(20-Mar-27), 11566173(03-Apr-27), 11566883(10-Apr-27), 11568153(16-Apr-27), 11570813(08-May-27); 360-2080-01/20886333004342/00886333004348/11563564(26-Mar-2027), 11566036(8-Apr-2027), 11567992(16-Apr-2027), 11570142(1-May-27), 11570863(8-May-27); 360-2080-02/20886333224047/00886333224043/11562964(07-Mar-27), 11563922(15-Mar-27), 11564189(22-Mar-27); 360-2080-03/20886333224054/00886333224050/11563443(15-Mar-27), 11566936(11-Apr-27), 11567889(22-Apr-2027); 370-1080-01/20886333004380/00886333004386/11564795(26-Mar-27); 370-1080-02/20886333224061/00886333224067/11562608(05-Mar-27), 11562748(04-Mar-27), 11564843(26-Mar-27), 11566037(08-Apr-27), 11571101(30-Apr-27), 11571360(06-May-27); 370-1080-03/20886333224078/00886333224074/11564844(22-Mar-27), 11566690(16-Apr-27), 11571100(01-May-27), 11573030(13-May-27); 370-1580-01/20886333004366/00886333004382/11564366(26-Mar-27); 370-1580-02/20886333224085/00886333224081/11571824(06-May-27), 11562114(07-Mar-27), 11566038(08-Apr-27), 11571824(06-May-27); 370-1580-03/20886333224092/00886333224098/11569414(22-Apr-27), 11571104(01-May-27); 763114100x/20886333006643/00886333006649/11563673(11-May-2029), 11570356(23-Apr-2029), 11571058(4-Apr-2029), 11572456(29-May-2029), 11572868(13-May-2029), 11573300(22-May-2029); 763116100X/20886333006612/00886333006618/11562815(7-Mar-2029), 11571061(29-Apr-2029); 763116160X/20886333006605/00886333006601/11571063(1-May-2029); 763118100X/20886333006582/00886333006588/11564330(26-Mar-2029); 763118200X/20886333006650/00886333006656/11562085(5-Mar-2029), 11571065(4-APR-2029); 763120100X/20886333006568/00886333006564/11564331(26-Mar-2029); 763120160X/20886333006575/00886333006571/11565618(10-Apr-2029); 763418200X/20886333006803/00886333006809/11566213(10-Apr-2029); 763418250X/20886333006810/00886333006816/11564594(22-Mar-2029), 11565619(4-Apr-2029), 11572175(22-May-2029); 763114200X/20886333006629/00886333006625/11566106(4-Apr-2029)
Devices named in this recall
25 devices in the FDA device registry whose identifier appears in the recall's code information.
- BioPince Ultra Full Core Biopsy Instrument 360-1080-02Argon Medical Devices, Inc. · Instrument, Biopsy1 recall27 reports
- BioPince™ Full Core Biopsy Instrument 360-1580-01Argon Medical Devices, Inc. · Instrument, Biopsy1 recall25 reports
- BioPince Ultra Full Core Biopsy Instrument 360-1080-03Argon Medical Devices, Inc. · Instrument, Biopsy1 recall2 deaths15 reports
- BioPince™ Full Core Biopsy Instrument 360-1080-01Argon Medical Devices, Inc. · Instrument, Biopsy1 recall13 reports
- BioPince Ultra Full Core Biopsy Instrument 360-2080-02Argon Medical Devices, Inc. · Instrument, Biopsy1 recall13 reports
- BioPince™ Ultra Full Core Biopsy Instrument 370-1080-02Argon Medical Devices, Inc. · Instrument, Biopsy1 recall12 reports
- BioPince™ Full Core Biopsy Instrument 370-1580-01Argon Medical Devices, Inc. · Instrument, Biopsy1 recall10 reports
- BioPince Ultra Full Core Biopsy Instrument 360-1580-03Argon Medical Devices, Inc. · Instrument, Biopsy1 recall7 reports
- BioPince™ Full Core Biopsy Instrument 360-2080-01Argon Medical Devices, Inc. · Instrument, Biopsy1 recall6 reports
- BioPince™ Full Core Biopsy Instrument 370-1080-01Argon Medical Devices, Inc. · Instrument, Biopsy1 recall6 reports
- BioPince Ultra Full Core Biopsy Instrument 360-1580-02Argon Medical Devices, Inc. · Instrument, Biopsy1 recall6 reports
- Tru-Core™ II Biopsy Instrument 763116100XArgon Medical Devices, Inc. · Instrument, Biopsy1 recall4 reports
- Tru-Core™ II Biopsy Instrument 763116160XArgon Medical Devices, Inc. · Instrument, Biopsy1 recall3 reports
- Tru-Core™ II Biopsy Instrument 763114100XArgon Medical Devices, Inc. · Instrument, Biopsy1 recall3 reports
- BioPince™ Ultra Full Core Biopsy Instrument 370-1580-02Argon Medical Devices, Inc. · Instrument, Biopsy1 recall3 reports
- Tru-Core™ II Biopsy Instrument 763120160XArgon Medical Devices, Inc. · Instrument, Biopsy1 recall2 reports
- Tru-Core™ II URO Biopsy Instrument 763418200XArgon Medical Devices, Inc. · Instrument, Biopsy1 recall2 reports
- Tru-Core™ II Biopsy Instrument 763118100XArgon Medical Devices, Inc. · Instrument, Biopsy1 recall1 report
- BioPince Ultra Full Core Biopsy Instrument 360-2080-03Argon Medical Devices, Inc. · Instrument, Biopsy1 recall1 report
- BioPince™ Ultra Full Core Biopsy Instrument 370-1080-03Argon Medical Devices, Inc. · Instrument, Biopsy1 recall1 report
- Tru-Core™ II Biopsy Instrument 763120100XArgon Medical Devices, Inc. · Instrument, Biopsy1 recall0 reports
- Tru-Core™ II Biopsy Instrument 763114200XArgon Medical Devices, Inc. · Instrument, Biopsy1 recall0 reports
- Tru-Core™ II Biopsy Instrument 763118200XArgon Medical Devices, Inc. · Instrument, Biopsy1 recall0 reports
- Tru-Core™ II URO Biopsy Instrument 763418250XArgon Medical Devices, Inc. · Instrument, Biopsy1 recall0 reports
- BioPince™ Ultra Full Core Biopsy Instrument 370-1580-03Argon Medical Devices, Inc. · Instrument, Biopsy1 recall0 reports
Product lines
- BioPince Ultra Full Core Biopsy InstrumentArgon Medical Devices, Inc. · 10 models · 85 reports · 1 recall
- Tru-Core II Biopsy InstrumentArgon Medical Devices, Inc. · 8 models · 13 reports · 1 recall
- BioPince Full Core Biopsy InstrumentArgon Medical Devices, Inc. · 5 models · 60 reports · 1 recall
- Tru-Core II URO Biopsy InstrumentArgon Medical Devices, Inc. · 2 models · 2 reports · 1 recall
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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