FDA recall, , High risk
Argon Medical Devices Cardiovascular and Biopsy Trays
Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F may not meet sterility release criteria.
Summary by Recall Canary from the FDA notice
What happened
Argon Medical Devices, Inc. of Athens, Texas, recalled several trays and kits because they contain Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
The products include the General Biospy Tray, Arterial Line Kit 20ga x 6, Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, One-Piece Introducer Tray, T-Lok Bone Marrow Tray, and Bone Marrow Tray. The recall began June 1, 2026, and was added to the FDA's Enforcement Report on July 10, 2026. Distribution was US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
6 products
Match the UDI-DI, lot code and reference number listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
- UDI-DI
- 20886333214499
- 00886333214495
- 11656891
- 20886333214635
- 00886333214631
- 11658984
- Lot code
- 497434
General Biospy Tray
- UDI-DI
- 20886333001594
- 00886333001590
- 11649760
- Reference number
- GUTS1000
- Lot code
- GUTS1000
Arterial Line Kit 20ga x 6
- UDI-DI
- 20886333212884
- 00886333212880
- 11655174
- 11655183
- 11655185
- 11659131
- Reference number
- 400115A
- Lot code
- 400115A
Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
- UDI-DI
- 20886333217636
- 00886333217632
- 11656898
- 20886333217643
- 00886333217649
- 11654475
- 11654478
- Lot code
- 008416A
T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL
- UDI-DI
- 20886333007862
- 00886333007868
- 11650679
- 20886333007602
- 00886333007608
- 11654764
- 20886333007763
- 00886333007769
- 11650887
- Lot code
- BMT1104STL
Bone Marrow Tray, REF: CB0033TL; CB0355TLA
- UDI-DI
- 20886333217308
- 00886333217304
- 11650820
- 11652276
- 20886333217698
- 00886333217694
- 11651977
- Lot code
- CB0033TL
Recall details
- Company began the recall
- Sold in
Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
- Company
- Argon Medical Devices, IncAthens, Texas
- Hazard
- Sterility problem
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 99069
- Recall numbers
- Z-2704-2026 to Z-2709-2026
All recalls from Argon Medical Devices, Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
