Argon Medical Devices Recalls One-Piece Introducer Tray
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Argon Medical Devices, Inc. is recalling 200 units of One-Piece Introducer Tray kits due to sterility concerns with included lidocaine ampules.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 10, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Argon Medical Devices, Inc. initiated a voluntary recall of One-Piece Introducer Tray kits because they contain Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules that were subject to another recall for not meeting release criteria for sterility.
Which Products Are Affected
The recall covers One-Piece Introducer Tray, REF: 497455 and 497434 (cardiovascular). A total of 200 units are affected. Distribution was nationwide in the United States including Puerto Rico, and to Trinidad and Tobago. Specific lots include: 497434/20886333214499:00886333214495/11656891 (exp. 7/19/2027) and 497455/20886333214635:00886333214631/11658984 (exp. 7/19/2027). Recall number Z-2705-2026. Classification: Class I.
What You Should Do
Consumers should follow guidance from the recalling firm regarding the affected kits.
Why This Matters
This is a Class I recall involving potential sterility issues with a medical device distributed across the United States.
Source
FDA recall Z-2705-2026, Argon Medical Devices, Inc., Athens, TX.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,050 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to August 10, 2026.
Frequently Asked Questions
Common questions about this FDA recall.