Reported Aug 19, 2026 · Ongoing · Updated Aug 25, 2026
Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule…
Spectra Medical Devices, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Spectra Medical Devices, Llc · 299 Ballardvale St · Wilmington, MA · 01887-1066
Is this the product you have?
- Brand NameElevaris/Spectra
- Medical Devices Product NameSodium Chloride Injection, 0.9%
- USP 10mL Ampule Model/Catalog NumberAMPUL10MLK. Sodium Chloride Flush for IV tubing systems and indwelling intravascular access devices
- Lot codes and dates
- Lot CodeProduct
- codes1510-1 (individual
- ampule) / 1510-2 (carton) LotsAB3005, 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
- Amount recalled
- TBD
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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