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Spectra Medical Devices, Llc FDA Recalls
2 recalls on file across devices, drugs, 1 of them Class I and 2 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/CatClass IJul 6, 2026Manufacturing firm, Huons, was cited for issues regarding pr |
| Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, WilminClass IIMay 12, 2026Lack of Assurance of Sterility |