Spectra Medical Devices recalls

2 official recalls and safety alerts involving Spectra Medical Devices since 2026-06, from FDA · Device, FDA · Drug. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Spectra Medical Devices or the relevant agency.

1. 2026-08-19
2. US
   Drugs & medicalClass I

   Spectra Medical Devices, Llc recalls Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number:…

   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…

   FDA · DeviceSpectra Medical Devices, LlcDistributed in the United States to medical device kit packers in six (6)…Official notice →
3. 2026-06-10
4. US
   Drugs & medicalClass II

   Spectra Medical Devices, Llc recalls Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made…

   Lack of Assurance of Sterility

   FDA · DrugSpectra Medical Devices, LlcUSA NationwideOfficial notice →