Argon Medical Devices Recalls Transjugular Liver Biopsy Systems
Argon Medical Devices is recalling 583 Transjugular Liver Biopsy Systems due to a manufacturing error that may cause the sheath to separate during use.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and the source text explicitly states the defect could result in permanent damage to a body structure or permanent impairment of a body function, meeting the criteria for a Severe rating.
Plain-English summary
Argon Medical Devices, Inc. is recalling 583 units of the TLAB Transjugular Liver Biopsy System (REF: TL-18N). The affected products include a 1/18 GA Flexcore Biopsy Needle, a 1/7F Introducer Sheath with Curved Metal Stiffener, and 4 Tissue Removal Swabs. The recall covers specific lot numbers: 1394204, 1424962, 1464709, 1473181, 1477229, 1481735, and 1495182.
The recall is due to a manufacturing error that creates a potential for the sheath within the biopsy kit to separate during use if the tip is flexed or experiences bending stresses. This defect could result in the need for surgical intervention to preclude or reverse permanent damage to a body structure or permanent impairment of a body function.
The affected products were distributed in the United States (including Puerto Rico) and internationally to countries including Switzerland, Saudi Arabia, Hong Kong, Thailand, Portugal, Taiwan, Austria, Brazil, Netherlands, Italy, Germany, Colombia, Singapore, Canada, Vietnam, Slovakia, and Spain. Healthcare providers and facilities should stop using the affected units and contact Argon Medical Devices for further instructions.
The recalled product
- Product
- Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO,
- Manufacturer
- Argon Medical Devices, Inc
- Category
- Medical Device — Biopsy System
- Affected units
- 583
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 (7)
- Lot Number: 1394204
- 1424962
- 1464709
- 1473181
- 1477229
- 1481735
- 1495182
Distribution
Part of a larger recall action
This product is one of 6 recalled by Argon Medical Devices, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · Argon Medical Devices, Inc
See all →- HighPeripherally Inserted Central Catheters Recalled Due to Hub Leaking and Cracking Risk
FDA (Devices) · 2026-08-05
- HighMidline Catheter Recalled Over Risk of Leaking or Cracking at Hub
FDA (Devices) · 2026-08-05
- SevereTransvenous Pacing Electrode Tray with Bipolar Balloon Pacing Electrode Recalled
FDA (Devices) · 2026-07-22
- SevereArterial Line Kit with Lidocaine HCL Injection Fails Sterility Testing
FDA (Devices) · 2026-07-22
- SevereBone Marrow Tray kits recalled due to sterility failure
FDA (Devices) · 2026-07-22
Same hazard · structural failure
See all →- High
- ModerateQuantum Ops Recalls ADAPTABLE Beach Chair Surgical Patient Positioners
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Assembly Disconnect Risk
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Detachment Risk
FDA (Devices) · 2026-10-14
- SeverePacearth Recalls Swing Seats Due to Serious Injury Risk from Falling
CPSC · 2026-10-08
Similar recalls
- HighArgon Medical Devices Recalls T-Lok Bone Marrow Biopsy Needles
FDA (Devices) · 2015-07-29
- ModerateArgon Medical Devices Recalls BioPince Biopsy Instruments Due to Labeling Error
FDA (Devices) · 2020-07-01
- HighArgon Medical Devices Recalls Arterial Line Kits Due to Needle Defect
FDA (Devices) · 2020-05-20
- HighArgon Medical Devices Recalls ClosureFast Introducer Sheath Sets Due to Assembly Error
FDA (Devices) · 2016-03-09
- ModerateArthrex Recalls Tibial Opening Wedge Osteotomy Plates Due to Processing Error
FDA (Devices) · 2021-04-21
- HighArgon Medical Devices Recalls MicroStic Plus Sheaths Due to Dilator Hub Defect
FDA (Devices) · 2016-10-12