The Recall Desk
HighFDA (Devices)·Z-0354-2022·Announced 2021-12-15

SuperCore Biopsy Instruments Recalled for Component Detachment Risk

Argon Medical Devices is recalling 79,910 SuperCore Biopsy Instruments due to housing and plunger components detaching from the semi-automatic devices. The devices were distributed worldwide and throughout the United States.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II FDA recall involving a medical device used in invasive procedures. No injuries or hospitalizations are reported in the source material. Per the rubric, risk-of-harm products where injury has not been reported score 3.

Plain-English summary

Argon Medical Devices, Inc. is recalling SuperCore Biopsy Instruments due to housing and plunger components detaching from the semi-automatic devices. Approximately 79,910 devices are affected by this Class II recall.

The affected devices were distributed worldwide and throughout multiple U.S. states. International distribution included countries across Asia, Europe, the Middle East, and the Americas, as well as other regions.

Affected devices are identified by specific reference numbers and lot numbers provided for each product variant. The recalled instruments include multiple needle gauges and lengths, as well as coaxial and other configurations.

The recalled product

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
Manufacturer
Argon Medical Devices, Inc
Category
Medical Device — Biopsy Instrument
Hazard
  • component-detachment

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

Related recalls

Same category