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Class IOngoing

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

Recall date · record updated Aug 19, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Spectra Medical Devices, Llc
Reason
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.
Hazard
FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).
Who’s affected
Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA.
Where
California, Florida, North Carolina, Oklahoma, Texas, Virginia
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98777…

Products

  1. 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.

    Codes/lots: 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: TBDRecall no. Z-2873-2026Class I

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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