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One-Piece Introducer Tray, REF: 497455, 497434… recallZ-2705-2026 · Argon Medical Devices, Inc · initiated Jun 1, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Argon Medical Devices, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Material/Component Contamination

What the company is doing

On 6/1/2026, correction notices were sent to customers who were asked to do the following: 1) Do not use the affected Lidocaine vials included in affected Kits and Sets in scope of this notice 2) Review your inventory for any product covered by this Medical Device Notification. If any items from the affected lot are identified: - Place a copy of this notice with the affected product - Apply the enclosed stickers to the packaging (kit) to clearly identify the item and remind users to discard affected lidocaine. 3) At the point of use, upon opening the kit, discard the affected Lidocaine vials in accordance with your facility's procedures. 4) Obtain Lidocaine separately through your facility pharmacy and prepare / administer it per institutional protocols prior to the procedure. 5) Complete and return the response form via email [email protected]

Recall details

Recall number
Z-2705-2026
Status
Open, Classified
Initiated by the company
Jun 1, 2026
Posted by the FDA
Jul 10, 2026
Recalling firm
Argon Medical Devices, Inc
Quantity
200
Product code
DRE
FDA submissions
K780126
Distribution
Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

14 devices cleared under K780126 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 99069).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page