FDA Device recall Z-0354-2022
SuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE BIOPSY INSTR 14GA X 9CM
- FDA Device
- Class II
- ongoing
- Published 2021-12-15
On 2021-12-15 the FDA classified a Class II recall of SuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE BIOPSY INSTR 14GA X 9CM by Argon Medical Devices, citing due to component (housing and plunger) detaching from the semi-automatic biopsy instruments.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0354-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-10-04 |
| Published | 2021-12-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Argon Medical Devices |
| Distribution | US |
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.
Identifiers
| code_info | REF/Product Description: 701114090/SUPERCORE BIOPSY INSTR 14GA X 9CM; Lot Numbers: 11364350 11365643 11368388 11371872…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; |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0354-2022%22
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