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Spectra Medical Devices, Llc recalls Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Cat
Recalled August 19, 2026 · FDA recall Z-2873-2026 · Spectra Medical Devices
Hazard
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 Class I
Units
TBD
Sold at
Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA.
Description
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.
Product
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.
Manufacturer(s)
Spectra Medical Devices, Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →