Stop using now Medical device recall · FDA · Published July 6, 2026

Spectra Medical Devices Sodium Chloride Injection Recall: Risk of Infection

Spectra Medical Devices recalls 10mL Sodium Chloride Injection ampules due to potential contamination. If sterility is compromised, patients may develop infections, micro-clots, or organ failure. Affected lots include AB3005-AB5008.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2873-2026Medical device Spectra Medical Devices ›

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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.

✎ GovInfoNow plain-language explainer

Spectra Medical Devices is recalling 10mL Sodium Chloride Injection ampules that may be contaminated. If the solution is not sterile, patients could get infections, blood clots, or organ damage. This is a serious risk for medical users. Read more at govinfonow.com/recall/459416-spectra-medical-devices-sodium-chloride-injection-recall-risk-of-infection.

Source Summary by GovInfoNow · govinfonow.com/recall/459416-spectra-medical-devices-sodium-chloride-injection-recall-risk-of-infection · Updated August 27, 2026 · FDA enforcement record: FDA #Z-2873-2026

Cite this page

“Spectra Medical Devices Sodium Chloride Injection Recall: Risk of Infection.” GovInfoNow, updated August 27, 2026. https://govinfonow.com/recall/459416-spectra-medical-devices-sodium-chloride-injection-recall-risk-of-infection. Based on FDA recall #Z-2873-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2873-2026%22&limit=1).

The FDA announced on July 6, 2026, that Spectra Medical Devices, Llc is recalling Sodium Chloride Injection, 0.9%, USP 10mL Ampules due to sterility assurance issues. The agency issued recall number Z-2873-2026 for the voluntary Class I action.

How to tell if you have it

Brand: Elevaris/Spectra Medical Devices
Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule
Model/Catalog Number: AMPUL10MLK
Lot Codes: AB3005 through AB3010, AB4001 through AB4006, AB5001 through AB5008

The hazard

The 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 exposure may trigger inflammatory responses, infections, micro-clots, and organ failure.

Context

GovInfoNow's records show Spectra Medical Devices, Llc has one other recall on record since May 12, 2026, specifically the Lidocaine Ampules recall due to sterility risk. Other recent recalls of similar products include the Arrow Pacing PSI Kit Recall (April 21, 2026) and Medical Action Industries Epidural Kits Recall (July 23, 2026).

How to tell if you have this one

Check for ampules labeled 'Sodium Chloride Injection, 0.9%, USP 10mL' with lot codes AB3005 through AB5008. The product is sold in cartons with codes 1510-1 (ampule) and 1510-2 (carton).

Brand
Spectra Medical Devices
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Stop Using Now
Immediately discard any recalled ampules with lot codes AB3005 to AB5008.

Where it went and when

Where it was distributed

Distributed in 6 states.

FDA distribution: “Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Florida, North Carolina, Oklahoma, Texas, Virginia.

Recall timeline

FDA published this recall 44 days after the firm started it.

Jul 6, 2026Firm started the recall
Aug 11, 2026FDA classified it Class I
Aug 19, 2026Published in FDA’s Enforcement Report
Aug 27, 2026Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/459416-spectra-medical-devices-sodium-chloride-injection-recall-risk-of-infection">Spectra Medical Devices Sodium Chloride Injection Recall: Risk of Infection (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2873-2026 (July 6, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2873-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.