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Spectra Medical Devices Recalls
2 recalls on record · June 10, 2026 to August 19, 2026 · Drugs, Medical Devices
August 19, 2026Medical DevicesFDA
Spectra Medical Devices, Llc recalls Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Cat
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.
June 10, 2026DrugsFDA
Spectra Medical Devices, Llc recalls Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmin
Hazard: Lack of Assurance of Sterility