CLASS I ONGOING Device recall · Reported 22 Jul 2026 · FDA Enforcement Report

One-Piece Introducer Tray recalled by Argon Medical Devices

Argon Medical Devices is recalling One-Piece Introducer Tray, distributed nationwide in the US. The recall was initiated on 1 Jun 2026 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesREF/UDI-DI Box:Unit/Lot(Expiration): 497434/20886333214499:00886333214495/11656891(7/19/2027); 497455/20886333214635:00886333214631/11658984 (7/19/2027);

Quantity recalled200

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2705-2026
FDA event ID: 99069
Recalling firm: Argon Medical Devices, Athens, TX
Classification: Class I
Status: Ongoing
Recall initiated: 1 Jun 2026
FDA classified: 10 Jul 2026
Reported: 22 Jul 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

1 Jun 2026	Recall initiated by company
10 Jul 2026	Classified by FDA	+39 days
22 Jul 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

5 other products · FDA event 99069

This product is part of a recall event; the main page for the event is General Biospy Tray recalled by Argon Medical Devices.

Reported	Class	Recall	Company	Reason	Where
22 Jul 2026	CLASS I	General Biospy Tray recalled by Argon Medical Devices	Argon Medical Devices	Sterility	Nationwide
22 Jul 2026	CLASS I	Arterial Line Kit recalled by Argon Medical Devices	Argon Medical Devices	Sterility	Nationwide
22 Jul 2026	CLASS I	Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing recalled	Argon Medical Devices	Sterility	Nationwide
22 Jul 2026	CLASS I	T-Lok Bone Marrow Tray recalled by Argon Medical Devices	Argon Medical Devices	Sterility	Nationwide
22 Jul 2026	CLASS I	Bone Marrow Tray recalled by Argon Medical Devices	Argon Medical Devices	Sterility	Nationwide

More recalls from Argon Medical Devices

All 50

Reported	Class	Recall	Company	Reason	Where
5 Aug 2026Device	CLASS II	L-Cath PICC S/L Peripherally Inserted Central Catheter: (1.9F) recalled	Argon Medical Devices	Labeling Errors	28 states
5 Aug 2026Device	CLASS II	L-Cath Midline S/L Catheter (3F) recalled by Argon Medical Devices	Argon Medical Devices	Labeling Errors	28 states
22 Jul 2026Device	CLASS I	Bone Marrow Tray recalled by Argon Medical Devices	Argon Medical Devices	Sterility	Nationwide
22 Jul 2026Device	CLASS I	T-Lok Bone Marrow Tray recalled by Argon Medical Devices	Argon Medical Devices	Sterility	Nationwide
22 Jul 2026Device	CLASS I	Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing recalled	Argon Medical Devices	Sterility	Nationwide

Other Heart & Vascular Devices recalls

All 6,220

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	TufTex¿ Over-the-Wire Embolectomy Catheter recalled	LeMaitre Vascular	Other	Nationwide
14 Oct 2026Device	CLASS II	Endovascular Pack kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled	Stryker Sustainability Solutions	Particulate Matter	Nationwide
7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide