FDA recall, , High risk
Spectra Medical Devices Sodium Chloride Injection
Sodium Chloride Injection, 0.9%, USP 10mL Ampule may have compromised sterility, exposing patients to microorganisms, endotoxins, or foreign matter.
Summary by Recall Canary from the FDA notice
What happened
Spectra Medical Devices, LLC of Wilmington, Massachusetts recalled Sodium Chloride Injection, 0.9%, USP 10mL Ampule, brand name Elevaris/Spectra Medical Devices, on July 6, 2026. 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, which may trigger inflammatory responses, infections, micro-clots, and organ failure.
The product, for IV tubing systems and indwelling intravascular access devices, was distributed in the United States to medical device kit packers in six states: California, Florida, North Carolina, Oklahoma, Texas, and Virginia. The FDA added it to its Enforcement Report and classified it on August 11, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number and lot code listed under your product.
Sodium Chloride Injection, 0.9%, USP 10mL Ampule
- Model number
- AMPUL10MLK
- Lot code
- 1510-1
- 1510-2
- AB3005
- AB3006
- AB3007
- AB3008
- AB3009
- AB3010
- AB4001
- AB4002
- AB4003
- AB4004
- AB4005
- AB4006
- AB5001
- AB5002
- AB5003
- AB5004
- AB5005
- AB5006
- AB5007
- AB5008
Recall details
- Company began the recall
- Sold in
Distributed in the United States to medical device kit packers in six (6) states - California, Florida, North Carolina, Oklahoma, Texas, Virginia.
- Company
- Spectra Medical Devices, LlcWilmington, Massachusetts
- Recalls that follow it
- Bard Access Systems DuoGlide and Power-Trialysis Short-Term Straight Dialysis Catheter
- Hazard
- Sterility problem
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 98777
- Recall number
- Z-2873-2026
All recalls from Spectra Medical Devices, Llc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
