FDA Closes Class I Recall of Spectra Medical Devices Sodium Chloride Injection

The FDA has closed the recall of Spectra Medical Devices' Sodium Chloride Injection, 0.9%, USP 10mL Ampule, citing completed corrective actions.

2 reports on this incident · first at Aug 26, 2026, 9:16 p.m. ET

By AI ReporterWritten Aug 26, 2026, 9:24 p.m. ET

Developing · checked 14 min ago

This recall is open. The agency updates its record as an action is expanded, reclassified or terminated, and this page is rewritten when it does.

We last searched for new coverage of this at Aug 26, 2026, 11:39 p.m. ET — checked 14 min ago.

The U.S. Food and Drug Administration (FDA) has closed the recall of 's Sodium Chloride Injection, 0.9%, USP 10mL Ampule (Model/Catalog Number: AMPUL10MLK), according to the agency's enforcement report dated August 19, 2026. The recall, initiated July 6, 2026, was classified as , the FDA's most serious category, indicating a reasonable probability that use of the product could cause serious harm or death. The recall was issued because the manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter, potentially triggering inflammatory responses, infections, micro-clots, and organ failure. The product, a sterile saline flush for IV tubing systems and indwelling intravascular access devices, was distributed to medical device kit packers in six states: CA, FL, NC, OK, TX, and VA. The FDA's enforcement report lists the recall number as and notes the status as "" as of the report date. The agency's database records no other enforcement actions by Spectra Medical Devices. The closure indicates the FDA considers the recall carried out, but the agency has not provided identifying lot codes or expiration dates for the affected product.

Earlier reports

Aug 26, 2026, 9:16 p.m. ETFirst report
FDA Class I Recall Issued for Spectra Medical Devices Sodium Chloride Injection; No Identifying Codes Provided
The U.S. Food and Drug Administration (FDA) has issued a Class I recall for Sodium Chloride Injection, 0.9%, USP 10mL Ampules, distributed by Spectra Medical Devices, LLC of Wilmington, MA. The recall, initiated on July 6, 2026, and reported on August 19, 2026, affects product distributed to medical device kit packers in six states: CA, FL, NC, OK, TX, and VA. The recall number is Z-2873-2026 and the status is ongoing.
The FDA's enforcement report states that the manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product's sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter, which may trigger inflammatory responses, infections, micro-clots, and organ failure. The quantity of affected product is listed as TBD.
The recall notice does not provide identifying codes such as lot numbers or UPC codes. This means that a reader with the product may not be able to determine from the notice alone whether their specific product is covered by the recall. Consumers and healthcare providers are advised to contact Spectra Medical Devices, LLC for further guidance.
According to the FDA's classification definitions, Class I is the most serious category, used when there is a reasonable probability that using the product will cause serious harm or death. The FDA's database records no other enforcement actions by Spectra Medical Devices, LLC.
The product is a sterile saline solution used to flush intravenous lines and catheters, typically sold as a prescription-only institutional supply to hospitals and clinics.

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Version 127 Aug 2026, 01:16current
First published.
Version 127 Aug 2026, 01:24current
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