Argon Medical Devices Recalls Arterial Line Kit
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Argon Medical Devices, Inc. is recalling 440 Arterial Line Kit 20ga x 6 units (REF 400115A) due to sterility concerns with contained 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
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall were recalled due to not meeting release criteria for sterility.
Which Products Are Affected
Arterial Line Kit 20ga x 6, REF: 400115A. Product quantity: 440 units. Distribution: US nationwide including Puerto Rico; also to Trinidad and Tobago. Code info: REF/UDI-DI Box:Unit/Lot(Expiration): 400115A/20886333212884:00886333212880/11655174(7/19/2027), 11655183(7/19/2027), 11655185(7/19/2027), 11659131(7/19/2027). Recall number: Z-2708-2026. Classification: Class I. Recall initiation date: 20260601.
What You Should Do
No specific consumer action steps are provided in the recall data.
Why This Matters
This is a Class I recall involving potential sterility issues with a medical device distributed nationwide.
Source
FDA recall Z-2708-2026
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 (867 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.