FDAFDA recall Z-2873-2026 · Aug 19, 2026

Spectra Medical Devices, Llc: Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection recall

Recall found

Product

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.

Reason for recall

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 to do

FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.

Recall details

FDA classification: Class I: FDA's most serious class, where use of or exposure to the product may cause serious health problems or death.
Status: Ongoing
Codes, lots and dates: Lot Code: Product codes: 1510-1 (individual ampule) / 1510-2 (carton) Lots: AB3005, AB3006, AB3007, AB3008, AB3009, AB3010, AB4001, AB4002, AB4003, AB4004, AB4005 AB4006, AB5001, AB5002, AB5003, AB5004, AB5005,AB5006, AB5007, AB5008 No individual UDI, as this product is used only within convenience kits.
Quantity: TBD
Distribution: Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA.
Recalling firm: Spectra Medical Devices, Llc, Wilmington, MA
Voluntary or mandated: Voluntary: Firm initiated
Recall started: 2026-07-06

Source: openFDA enforcement record Z-2873-2026 · search recall number Z-2873-2026 in FDA's Enforcement Report.

Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.