SuperCore Biopsy Instrument: REF/Product Description:… — Class II medical device recall Z-0354-2022
Ongoing recall by Argon Medical Devices, Inc, reported 2021-12-15, distributed nationwide. Due to component (housing and plunger) detaching from the semi-automatic biopsy instruments.
| Recall number | Z-0354-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Argon Medical Devices, Inc, Athens, TX, United States |
| Recall initiated | 2021-10-04 |
| Classified | 2021-12-09 |
| Reported by FDA | 2021-12-15 |
| Distributed | Nationwide (US) |
| Quantity | 79,910 devices |
| Reason classes | device malfunction |
| Lot numbers | 11361701, 11361702, 11362655, 11362716, 11362759, 11363229, 11363320, 11363516, 11364247, 11364350, 11364420, 11364421, 11364469, 11365643, 11365788, 11365935, 11366252, 11366253, 11366315, 11367439, 11367440, 11367443, 11367445, 11367446, 11368388, 11368389, 11368750, 11369916, 11370106, 11370107, 11370550, 11370552, 11370574, 11371012, 11371356, 11371357, 11371359, 11371404, 11371872, 11371876 and 125 more |
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 for recall
Due to component (housing and plunger) detaching from the semi-automatic biopsy instruments.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0354-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.