Spectra Medical Devices, LLC recalls Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection

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.

On July 6, 2026, firm sent letters titled, "Urgent: Medical Device Recall" to customers. Customers were instructed to examine their stock for affected product and discard or return any unused Sodium Chloride Flush ampules from the identified lot numbers. For affected products already in distribution, customers should instruct downstream customers to discard or return unused product. Customers were also instructed to use extra vigilance in detecting and reporting potential patient health concerns that may be related to this product.

• FDA enforcement recordOfficial FDA database entry for Z-2873-2026
• FDA 510(k) clearance · K082689The device's official FDA premarket clearance record
• FDA 510(k) clearance · K103740The device's official FDA premarket clearance record
• FDA device classification · NGTOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5200The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Spectra Medical Devices, LlcSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.