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SuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE BIOPSY INSTR 14GA X...

FDA Device Recall #Z-0354-2022 — Class II — October 4, 2021

Recall Summary

Recall Number Z-0354-2022
Classification Class II — Moderate risk
Date Initiated October 4, 2021
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Argon Medical Devices, Inc
Location Athens, TX
Product Type Devices
Quantity 79,910 devices

Product Description

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.

Distribution Pattern

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.

Lot / Code Information

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;

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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