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Class IOngoing

Argon Medical Devices, Inc recalls 6 products

Recall date · record updated Jul 22, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Argon Medical Devices, Inc
Reason
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
Hazard
FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).
Who’s affected
Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99069…

Products (6)

  1. 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: 950Recall no. Z-2704-2026Class I

  2. 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: 200Recall no. Z-2705-2026Class I

  3. General Biospy Tray, REF: GUTS1000

    Codes/lots: REF/UDI-DI Box:Unit/Lot(Expiration): GUTS1000/20886333001594:00886333001590/11649760(3/31/2028)Quantity: 1800Recall no. Z-2706-2026Class I

  4. 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: 850Recall no. Z-2707-2026Class I

  5. 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: 440Recall no. Z-2708-2026Class I

  6. 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: 680Recall no. Z-2709-2026Class I

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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