Elevaris/Spectra Medical Devices Product Name recall
Spectra Medical Devices, Llc recalled Elevaris/Spectra Medical Devices Product Name on August 19, 2026 because of manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. It was sold in CA, FL, NC, OK, TX, VA.
Why it was recalled
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.
What's recalled
Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride Flush for IV tubing systems and indwelling intravascular access devices.
Quantity: TBD
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Spectra Medical Devices, Llc, Wilmington, MA
- Date
- Severity
- Class I · most serious
the most serious: the product could cause serious health problems or death. - Where sold
- CA, FL, NC, OK, TX, VA
Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA. - Status
- Ongoing
- Recall number
- Z-2873-2026
- Source
- U.S. Food and Drug Administration
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