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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- Argon Medical Devices, Inc
- Hazard
- Affected units
- 79,910
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
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