# FDA recall Z-0354-2022

> **Argon Medical Devices, Inc** · Class II · device recall initiated 2021-10-04.

## 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/SUPERCO

## Reason for recall

Due to component (housing and plunger) detaching from the semi-automatic biopsy instruments.

## 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.

## Key facts

- **Recall number:** Z-0354-2022
- **Recalling firm:** Argon Medical Devices, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-10-04
- **Report date:** 2021-12-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Athens, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0354-2022

## Citation

> AI Analytics. FDA recall Z-0354-2022. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-0354-2022. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*