Critical Alert
Spectra Medical Devices Recalls Brand Name: Elevaris/Spectra Medical Devices Product Name
This is a Class I recall — the most serious type. There is a reasonable probability of serious health consequences or death.
Source: FDA
CriticalRecall #Z-2873-2026Medical Device
Spectra Medical Devices Recalls Brand Name: Elevaris/Spectra Medical Devices Product Name
Spectra Medical Devices, Llc · Class I — Most Serious
Product Description
Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride Flush for IV tubing systems and indwelling intravascular access devices.
Reason for Recall
Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This may trigger inflammatory responses, infections, micro-clots, and organ failure.
FDA Classification
Class I — Most Serious
A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Distribution
Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
A Class I recall — the FDA's most urgent classification — has been issued for a medical device recalled by Spectra Medical Devices, Llc on July 6, 2026. Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This recall affects TBD and was distributed nationwide. Class I recalls indicate a reasonable probability of serious health consequences or death. Consumers should stop using this product immediately.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.