Recall archive / FDA device enforcement
SuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE BIOPSY INSTR 14GA X 9CM; 701114150/SUPERCOR... — FDA record Z-0354-2022
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 Oct 4, 2021. 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
- SuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE BIOPSY INSTR 14GA X 9CM; 701114150/SUPERCORE BIOPSY INSTR 14GA X 15CM; 701116090/SUPERCORE BIOPSY INSTR 16GA X 9CM; 701118060/SUPERCORE BIOPSY INSTR 18GA X 6CM; 701118090/SUPERCORE BIOPSY INSTR 18GA X 9CM; 701118150/SUPERCORE BIOPSY INSTR 18GA X 15CM; 701118200/SUPERCORE BIOPSY INSTR 18GA X 20CM; 701120090/SUPERCORE BIOPSY INSTR 20GA X 9CM; 701120150/SUPERCORE BIOPSY INSTR 20GA X 15CM; 701120200/SUPERCORE BIOPSY INSTR 20GA X 20CM; 701214090/SUPERCORE BIOPSY INSTR W/COAXIAL - 14G x 9CM; 701214150/SUPERCORE BIOPSY INSTR W/COAXIAL - 14G x 15CM; 701216090/SUPERCORE BIOPSY INSTR W/COAXIAL - 16G x 9CM; 701216150/SUPERCORE BIOPSY INSTR W/COAXIAL - 16G x 15CM; 701218090/SUPERCORE BIOPSY INSTR W/COAXIAL - 18G x 9CM; 701218150/SUPERCORE BIOPSY INSTR W/COAXIAL - 18G x 15CM; 701218200/SUPERCORE BIOPSY INSTR W/COAXIAL - 18G x 20CM; 701220090/SUPERCORE BIOPSY INSTR W/COAXIAL - 20G x 9CM; 701220150/SUPERCORE BIOPSY INSTR W/COAXIAL - 20G x 15CM; 701220200/SUPERCORE BIOPSY INSTR W/COAXIAL - 20G x 20CM; 701114090M/SUPERCORE BIOPSY INSTR 14GA X 9CM-MAMMOTOME; 701114150M/SUPERCORE BIOPSY INSTR 14GA X 15CM-MAMMOTOME; 701116090M/SUPERCORE BIOPSY INSTR 16GA X 9CM-MAMMOTOME; SC 1409/PGI Supercore 14GA x 9CM; SC 1609/PGI Supercore 16GA x 9CM; SC 1806/PGI Supercore 18GA x 6CM;
- Reason
- Due to component (housing and plunger) detaching from the semi-automatic biopsy instruments.
- Classification
- Class II
- Recalling firm
- Argon Medical Devices, Inc
- Quantity
- 79,910 devices
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0354-2022
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/Product Description: 701114090/SUPERCORE BIOPSY INSTR 14GA X 9CM; Lot Numbers: 11364350 11365643 11368388 11371872 11374998 11376772 11378864 11382837 11385962 11389848 701114150/SUPERCORE BIOPSY INSTR 14GA X 15CM; Lot Numbers: 11368389; 11376773; 701116090/SUPERCORE BIOPSY INSTR 16GA X 9CM; Lot Numbers: 11362716; 11363320; 11365935; 11377634; 11381340; 11384192; 11388461; 11388552; 11389139; 701118060/SUPERCORE BIOPSY INSTR 18GA X 6CM; Lot Numbers: 11361702; 11365788; 11371012; 11374235; 11376598; 11379722; 11382768; 11383890; 11388656; 11389138; 701118090/SUPERCORE BIOPSY INSTR 18GA X 9CM; Lot Numbers: 11362759; 11363229; 11364420; 11367439; 11370106; 11372917; 11376074; 11377430; 11378217; 11383193; 11383785; 11384243; 11387238; 11388864; 701118150/SUPERCORE BIOPSY INSTR 18GA X 15CM; Lot Numbers: 11370107; 11375663; 11377819; 11382602; 11385139; 11385965; 11389140; 11390503; 701118200/SUPERCORE BIOPSY INSTR 18GA X 20CM; Lot Numbers: 11372225; 11374410; 11377431; 11384193; 11388505; 701120090/SUPERCORE BIOPSY INSTR 20GA X 9CM; Lot Numbers: 11374411; 11378865; 11383280; 701120150/SUPERCORE BIOPSY INSTR 20GA X 15CM; Lot Numbers: 11366252 11367440; 11376374; 11377820; 11381387; 11385960; 701120200/SUPERCORE BIOPSY INSTR 20GA X 20CM; Lot Numbers: 11366253; 11380018; 11388893; 701214090/SUPERCORE BIOPSY INSTR W/COAXIAL - 14G x 9CM; Lot Numbers: 11369916; 11378293; 11383587; 11387065; 701214150/SUPERCORE BIOPSY INSTR W/COAXIAL - 14G x 15CM; Lot Numbers: 11377967; 11382843; 701216090/SUPERCORE BIOPSY INSTR W/COAXIAL - 16G x 9CM; Lot Numbers: 11364421; 11367443; 11374684; 11379724; 11385966; 11388551; 701216150/SUPERCORE BIOPSY INSTR W/COAXIAL - 16G x 15CM; Lot Numbers: 11382845; 11388550; 11390251; 701218090/SUPERCORE BIOPSY INSTR W/COAXIAL - 18G x 9CM; Lot Numbers: 11361701; 11364247; 11367445; 11372366; 11374807; 11378687; 11383192; 11383784; 11388286; 701218150/SUPERCORE BIOPSY INSTR W/COAXIAL - 18G x 15CM; Lot Numbers: 11371404; 11373084; 11377636; 11380993; 11383194; 11383195; 11387400; 11387833; 11390504; 701218200/SUPERCORE BIOPSY INSTR W/COAXIAL - 18G x 20CM; Lot Numbers: 11366315; 11372227; 11377432; 11381193; 11382998; 11384716; 701220090/SUPERCORE BIOPSY INSTR W/COAXIAL - 20G x 9CM; Lot Numbers: 11367446; 11370574; 11375664; 11380589; 11381572; 11388507; 701220150/SUPERCORE BIOPSY INSTR W/COAXIAL - 20G x 15CM; Lot Numbers: 11368750; 11371876; 11372228; 11376375; 11377429; 11380104; 11384717; 11387148; 701220200/SUPERCORE BIOPSY INSTR W/COAXIAL - 20G x 20CM; Lot Numbers: 11362655; 11363516; 11372322; 11378295; 11380103; 11382884; 11387584; 701114090M/SUPERCORE BIOPSY INSTR 14GA X 9CM-MAMMOTOME; Lot Numbers: 11371356; 11382375; 11389615; 701114150M/SUPERCORE BIOPSY INSTR 14GA X 15CM-MAMMOTOME; Lot Number: 11371357; 701116090M/SUPERCORE BIOPSY INSTR 16GA X 9CM-MAMMOTOME; Lot Number: 11371359; SC 1409/PGI Supercore 14GA x 9CM; Lot Numbers: 11370550; 11384881; SC 1609/PGI Supercore 16GA x 9CM; Lot Number: 11370552; SC 1806/PGI Supercore 18GA x 6CM; Lot Numbers: 11375600; 11364469; |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WV. The countries of ALB, ARE, ARG, AUS, AUT, BEL, BGD, BRA, CAN, CHE, CHL, CHN, COL, CZE, DEU, ECU, ESP, EST, FRA, GBR, GRC, HKG, HUN, IND, IRN, ISR, ITA, JOR, JPN, MAR, MEX, MYS, NLD, NPL, NZL, PAK, PER, PHL, POL, PRT, SAU, SGP, SRB, THA, TUR, and TWN.
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
- Dec 15, 2021
- Recall initiation date
- Oct 4, 2021
- Center classification date
- Dec 9, 2021
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.