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FDA · Medical devicesClass I

Argon Medical Devices, Inc medical device recall: Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode…

Sterility concerns

Key facts

Agency
U.S. Food and Drug Administration (FDA)
Program
Medical devices
Classification
Class I
Status
Ongoing
Event ID
99069
Recall initiated
Jun 1, 2026
Classified by FDA
Jul 10, 2026
Posted in Enforcement Report
Jul 22, 2026
Recalling firm
Argon Medical Devices, Inc
Firm location
Athens, TX, United States
Initiated by
Voluntary: Firm initiated
Firm notified customers by
Letter
Products in this event
6

What to do

Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.

View the official FDA record ↗

Reason for recall

Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

What the classification means

  • Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on Jun 1, 2026. FDA classified it 39 days later, on Jul 10, 2026. This recall event covers 6 separate products, each with its own FDA recall number. Distribution reported by FDA: Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago. Argon Medical Devices, Inc has 23 recalls in our records.

Recalled products (6)

  • Z-2704-2026 Class I Ongoing

    Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A

    Codes / lots: REF/UDI-DI Box:Unit/Lot(Expiration): 008416A/20886333217636:00886333217632/11656898(7/19/2027); 008566A/20886333217643:00886333217649/11654475(12/31/2026), 11654478(7/19/2027)

    Quantity: 950

  • Z-2705-2026 Class I Ongoing

    One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular

    Codes / lots: REF/UDI-DI Box:Unit/Lot(Expiration): 497434/20886333214499:00886333214495/11656891(7/19/2027); 497455/20886333214635:00886333214631/11658984 (7/19/2027);

    Quantity: 200

  • Z-2706-2026 Class I Ongoing

    General Biospy Tray, REF: GUTS1000

    Codes / lots: REF/UDI-DI Box:Unit/Lot(Expiration): GUTS1000/20886333001594:00886333001590/11649760(3/31/2028)

    Quantity: 1800

  • Z-2707-2026 Class I Ongoing

    T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL

    Codes / lots: REF/UDI-DI Box:Unit/Lot(Expiration): BMT1104STL/20886333007862:00886333007868/11650679(11/30/2026); BMET1104TL/20886333007602:00886333007608/11654764(3/31/2028); BMT1104CATL/20886333007763:00886333007769/11650887(11/30/2026)

    Quantity: 850

  • Z-2708-2026 Class I Ongoing

    Arterial Line Kit 20ga x 6, REF: 400115A

    Codes / lots: REF/UDI-DI Box:Unit/Lot(Expiration): 400115A/20886333212884:00886333212880/11655174(7/19/2027), 11655183(7/19/2027), 11655185(7/19/2027), 11659131(7/19/2027);

    Quantity: 440

  • Z-2709-2026 Class I Ongoing

    Bone Marrow Tray, REF: CB0033TL; CB0355TLA

    Codes / lots: REF/UDI-DI Box:Unit/Lot(Expiration): CB0033TL/20886333217308:00886333217304/11650820(3/31/2028), 11652276(3/31/2028); CB0355TLA/20886333217698:00886333217694/11651977(3/31/2028);

    Quantity: 680

Source and freshness

Source
U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
Official notice
FDA Enforcement Report, event 99069
Raw record
openFDA API (JSON)
Dataset last updated by FDA
Nov 3, 2026
Imported by RecallRadar
Nov 4, 2026

Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.