Argon Medical Devices, Inc 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 20G Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 20G
Brand
Argon Medical Devices, Inc
Lot Codes / Batch Numbers
REF/Product Description: 701114090/SUPERCORE BIOPSY INSTR 14GA X 9CM, 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
Products Sold
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;
Argon Medical Devices, Inc is recalling SuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE BIOPSY INSTR 14GA X 9CM; due to Due to component (housing and plunger) detaching from the semi-automatic biopsy instruments.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to component (housing and plunger) detaching from the semi-automatic biopsy instruments.
Recommended Action
Per FDA guidance
On 09/30/2021, the firm sent an "Urgent-Product Recall Notice" letter to customers via US Postal Service Registered Mail informing them that the firm has received complaints regarding the semi-automatic Biopsy instrument coming apart during shipping or prior to use. According to the firm's investigation, the plastic housing and plunger can be separated more easily than normal for the lots manufactured during this time frame. Customers are instructed to return all affected product to the Recalling Firm's Athens TX facility using RGA#26683, attention Andrea Wieczor. Mailing address is: RGA# 26683 Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751 USA Att: Andrea Wieczor In addition, Customers are instructed to complete the response acknowledgement form included with the letter/email and return by fax, mail, or email as soon as possible. For questions. contact the Director, Post-Market Experience at email address Brian.Rogers@argonmedical.com, or contact Arbee Cummings at Arbee.Cummings@argonmedical.com or Andrea Wieczor at Andrea.Wieczor@argonmedical.com. (Updated information 11/2/2021), on 10/28/2021, the firm sent an updated "Urgent-Product Recall Notice for Additional Lots" letter via mail informing customers that they are expanding the recall to additional lots (list on the Inventory Sheet attached to recall notice). Again the Recalling Firm is instructing customer to return the affected product (listed on the Inventory Sheet).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026