Argon Medical Devices, Inc: Medical Device Recall in 2024 - (Recall #: Z-3192-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: July 2, 2024

Date Posted: October 2, 2024

Recall Number: Z-3192-2024

Event ID: 95119

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 95,430

Code Information:

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)

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated