Spectra Medical Devices Sodium Chloride Injection Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Spectra Medical Devices, Llc is recalling Sodium Chloride Injection, 0.9%, USP 10mL Ampules due to sterility assurance issues at the manufacturing firm.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 25, 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
Spectra Medical Devices, Llc initiated a voluntary recall of Sodium Chloride Injection, 0.9%, USP 10mL Ampules after the manufacturing firm Huons was cited for issues regarding product quality and sterility assurance. If product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter, which may trigger inflammatory responses, infections, micro-clots, and organ failure.
Which Products Are Affected
The recall involves Brand Name: Elevaris/Spectra Medical Devices, Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule, Model/Catalog Number: AMPUL10MLK. Lot codes affected include: AB3005, AB3006, AB3007, AB3008, AB3009, AB3010, AB4001, AB4002, AB4003, AB4004, AB4005, AB4006, AB5001, AB5002, AB5003, AB5004, AB5005, AB5006, AB5007, AB5008. Product codes are 1510-1 (individual ampule) and 1510-2 (carton). The product is Sodium Chloride Flush for IV tubing systems and indwelling intravascular access devices. Quantity is TBD. Distribution was limited to medical device kit packers in CA, FL, NC, OK, TX, and VA.
What You Should Do
Check product lot codes against the listed affected lots. The recall number is Z-2873-2026.
Why This Matters
This Class I recall involves potential exposure to contaminants that could lead to serious health consequences including infections and organ failure.
Source
FDA recall Z-2873-2026, https://www.fda.gov
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 (1,430 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to August 25, 2026.
Frequently Asked Questions
Common questions about this FDA recall.