Biopsy instrument packaging holes compromise sterile barrier integrity
Argon Medical Devices recalls BioPince Ultra and Tru-Core II biopsy instruments due to holes in packaging trays compromising the sterile barrier, which may allow microorganism introduction and infection risk.
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: FDA Class II recall involving sterile barrier compromise in medical devices with potential for microbial contamination. Per rubric, this is a risk-of-harm product where injury has not yet been reported, scoring High (3).
Plain-English summary
Argon Medical Devices, Inc. is recalling BioPince Ultra Full Core Biopsy Instrument and Tru-Core II Biopsy Instrument. Approximately 95,430 units have been distributed worldwide, including throughout the United States and internationally.
Holes have been identified in the packaging trays of these biopsy instruments, compromising the sterile barrier. This may result in cross-contamination or introduction of microorganisms at the biopsy access site.
Compromised sterile barriers can potentially lead to infectious complications including bacteremia or sepsis.
The recalled product
- Product
- BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02, 360-1580-03, 360-2080-01, 360-2080-02, 360-2080-03, 370-1080-01, 370-1080-02, 370-1080-03, 370-1580-01, 370-1580-02, 370-1580-03; Tru-Core II Biopsy…
- Manufacturer
- Argon Medical Devices, Inc
- Affected units
- 95,430
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)
- 11568010(16-Apr-2027)
- 11568790(1-May-2027)
- 11569552(7-May-2027)
- 11562475(05-Mar-27)
- 11562476(14-Mar-27)
- 11566932(08-Apr-27)
- 11567139(11-Apr-27)
- 11568361(16-Apr-27)
- 11569013(23-Apr-27)
- 11569844(29-Apr-27)
- 11571094(02-May-27)
- 11572044(08-May-27)
- 11572886(26-May-27)
- 360-1080-03/20886333224016/00886333224012/11569845(22-Apr-27)
- 11562477(04-Mar-27)
- 11564861(26-Mar-27)
- 11567888(12-Apr-27)
- 11568554(18-Apr-27)
- 11570075(04-May-27)
- 360-1580-01/20886333004359/00886333004355/11563438(21-Mar-2027)
Distribution
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