Argon Medical Devices Recalls Transvenous Pacing Electrode Trays
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Argon Medical Devices, Inc. is recalling 950 units of Transvenous Pacing Electrode Trays due to potential sterility issues from 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, medical-devices.
What Happened
Argon Medical Devices, Inc. initiated a voluntary recall of kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules that were subject to another recall and did not meet release criteria for sterility.
Which Products Are Affected
The affected products are Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A. A total of 950 units are involved. Distribution was nationwide in the United States including Puerto Rico, and to Trinidad and Tobago. Lot and expiration details include: 008416A/20886333217636:00886333217632/11656898(7/19/2027); 008566A/20886333217643:00886333217649/11654475(12/31/2026), 11654478(7/19/2027). Recall number Z-2704-2026.
What You Should Do
Consumers should refer to the recalling firm's notification for further instructions on affected products.
Why This Matters
This is a Class I recall involving potential sterility concerns with medical devices distributed across the United States and Puerto Rico.
Source
FDA recall Z-2704-2026, event ID 99069.
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 (1,062 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.