Who should I contact about this recall?

Contact Argon Medical Devices, Inc directly, or the distributor/pharmacy that supplied the product, to confirm whether your specific lot or unit is affected. Argus HQ aggregates the public FDA recall record and is not the recalling firm.

Has Argon Medical Devices, Inc had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 6 total FDA actions tied to Argon Medical Devices, Inc, including 6 recalls and 0 warning letters.

Recall Record: Class I Recall: Arterial Line Kit 20ga x 6, REF: 400115A by Argon Medical Devices, Inc

Here's the summary: FDA classified a recall by Argon Medical Devices, Inc as Class I, reported 20260722. The affected product is Arterial Line Kit 20ga x 6, REF: 400115A (recall number Z-2708-2026). 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.. Status: Ongoing. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field.

Key facts

Recalling firm	Argon Medical Devices, Inc
Manufacturer	Not disclosed in the FDA record.
Brand name	Not disclosed in the FDA record.
Product description	Arterial Line Kit 20ga x 6, REF: 400115A
Classification	Class I
Recall number	Z-2708-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
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 consumers should do

Facilities, clinicians, and consumers holding an affected unit or lot of Arterial Line Kit 20ga x 6, REF: 400115A should stop using it for the purpose described in the recall notice and hold remaining stock pending instructions from Argon Medical Devices, Inc. FDA recall records typically direct the recalling firm to notify known accounts directly with a recall letter describing the specific corrective action -- replacement, field correction, refund, or return. Anyone who received the product through a distributor rather than directly from Argon Medical Devices, Inc should confirm with their supplier whether their specific lot or unit is on the affected list, since recall notices are lot- or unit-specific and not every unit of a product line is necessarily included. Questions about a specific unit's status should go to Argon Medical Devices, Inc directly or to the distributor that supplied it; Argus HQ is a public-record aggregator, not the recalling firm, and cannot confirm individual unit status.

What this classification means

A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field. FDA's Center for Devices and Radiological Health (for devices) or Center for Drug Evaluation and Research (for drugs) reviews the classification and can require additional corrective action if the initial response is judged insufficient. Because this record is filed as Class I, professionals and consumers handling an affected lot should treat FDA's own classification -- not this page's summary of it -- as the authoritative risk signal. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field.

Argon Medical Devices, Inc’s FDA history

Argus HQ has recorded 6 total FDA actions tied to Argon Medical Devices, Inc: 0 warning letters, 6 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Why was Arterial Line Kit 20ga x 6, REF: 400115A recalled?: FDA's recall record states the reason as: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
Who should I contact about this recall?: Contact Argon Medical Devices, Inc directly, or the distributor/pharmacy that supplied the product, to confirm whether your specific lot or unit is affected. Argus HQ aggregates the public FDA recall record and is not the recalling firm.
Has Argon Medical Devices, Inc had other FDA recalls or enforcement actions?: Yes. Argus HQ has recorded 6 total FDA actions tied to Argon Medical Devices, Inc, including 6 recalls and 0 warning letters.
What is the FDA recall number for this event?: FDA recall number Z-2708-2026.

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Full FDA history for Argon Medical Devices, Inc

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Recall Record: Class I Recall: Arterial Line Kit 20ga x 6, REF: 400115A by Argon Medical Devices, Inc. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/recall/argon-medical-devices-z-2708-2026-2026-07-22

MLA

"Recall Record: Class I Recall: Arterial Line Kit 20ga x 6, REF: 400115A by Argon Medical Devices, Inc." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/recall/argon-medical-devices-z-2708-2026-2026-07-22.

Chicago

Argus HQ Research. "Recall Record: Class I Recall: Arterial Line Kit 20ga x 6, REF: 400115A by Argon Medical Devices, Inc." Digital Empire Holdings LLC. Accessed July 28, 2026. https://argushq.ai/recall/argon-medical-devices-z-2708-2026-2026-07-22.

BibTeX

@misc{argushq_argushq_ai_recall_argon_medical_devices_z_2708_2026_2026_07_22_2026,
  title = {Recall Record: Class I Recall: Arterial Line Kit 20ga x 6, REF: 400115A by Argon Medical Devices, Inc},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/recall/argon-medical-devices-z-2708-2026-2026-07-22},
  note = {Accessed: July 28, 2026}
}

Source: FDA.gov — Recalls ↗