# FDA device recall: Brand Name: Elevaris/Spectra Medical Devices  Product Name: Sodium Chloride Injection, 0.9%, USP 10mL  Ampule  Model/Cat

> recall · VERIFIED · 2026-07-06

Firm: Spectra Medical Devices, Llc · Class I · 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 fo

- Company: Spectra Medical Devices, Llc
- Sector: medical devices
- Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Source: MedFuel Intel news monitor. Verification tier: VERIFIED. Informational only, not investment advice. Corrections: media@medfuelinc.com.