Recall archive / FDA device enforcement
BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02... — FDA record Z-3192-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 2, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Argon Medical Devices, Inc
- Quantity
- 95,430
- Agency-reported status
- Ongoing
- Source record identifier
- Z-3192-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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) |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Oct 2, 2024
- Recall initiation date
- Jul 2, 2024
- Center classification date
- Sep 20, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.