Two IV Fluid Products Recalled Over Potential Particulate Contamination

Two major manufacturers have announced recalls involving certain intravenous fluid products after concerns that foreign particles may be present in the solutions.

B. Braun Medical Inc. and Baxter International Inc. are recalling specific lots of 0.9 percent Sodium Chloride Injection products distributed in the United States. The companies say the affected products may contain particulate matter that could create serious health risks if administered to patients.

So far, neither manufacturer has reported adverse events associated with the recalled products.

The recalls were announced through notices published by the U.S. Food and Drug Administration (FDA) on Aug. 28 and Aug. 26, respectively.

B. Braun Recalls Three Lots

B. Braun Medical, a Pennsylvania-based medical products manufacturer, is recalling three lots of its B. Braun 0.9 percent Sodium Chloride Injection USP.

The affected product comes in a 100 mL volume packaged in a 150 mL PAB container. The recalled lots are:

• J6B435
• J6B444
• J6B457

The products have an expiration date of April 30, 2027.

According to the FDA recall notice, the affected IV fluids were distributed to hospitals and other health care facilities throughout the country between Feb. 27 and Aug. 3.

The recall was initiated after zinc oxide particulate matter was found in the solution.

Sodium chloride injection is commonly used in medical settings as a source of water and electrolytes. It can also be used as a vehicle for administering certain medications. Because the solution is delivered directly into the bloodstream, contamination with foreign material can present a significant safety concern.

B. Braun has notified customers and distributors about the recall. The company has advised customers who have the affected products to return them to their place of purchase.

Baxter Recalls Two Lots

A separate recall involves Baxter International Inc., an Illinois-based health care company.

Baxter is recalling two lots of its 0.9 percent Sodium Chloride Injection USP supplied in 500 mL VIAFLEX plastic containers. The affected lot numbers are Y495523 and Y495523A, with an expiration date of Oct. 31, 2027.

The recall concerns the possible presence of fiberglass particulate matter in the solution.

Unlike the B. Braun product, the recalled Baxter solution was used as a priming solution for hemodialysis. Hemodialysis is a medical treatment that filters a patient's blood to remove excess fluid and waste products when the kidneys cannot perform those functions adequately.

The affected Baxter products were distributed from July 31 through Aug. 3 to health care customers in several states. Those states include Florida, Illinois, Indiana, Louisiana, Maryland, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, South Carolina, Texas, and Virginia.

Baxter said it is contacting customers by email and providing instructions for identifying and returning the affected products.

Why Particles in IV Fluids Can Be Dangerous

Particulate contamination is a particular concern for products administered intravenously because material in an injection can enter the bloodstream directly.

According to information included in the recall notices, administering an IV solution containing particulate matter may potentially result in serious or life-threatening complications.

Possible complications include pulmonary embolism, a condition in which a blood vessel supplying the lungs becomes blocked. Foreign particles can also obstruct other blood vessels. Such blockages may restrict blood flow and, in severe cases, cause tissue damage or organ injury.

Another possible complication is phlebitis, or inflammation of a vein. In some circumstances, inflammation can be associated with clot formation.

The presence of foreign material in the bloodstream may also contribute to other serious biological reactions, including damage to blood cells, organ dysfunction, and activation of the body's systemic immune response.

These potential risks are why manufacturers issue recalls when particulate contamination is identified or suspected, even when there have not yet been reports of patients experiencing harm.

No Adverse Events Reported So Far

Both companies have indicated that they are not aware of adverse events connected to the recalled products at this time.

That does not mean the recalled products should continue to be used. Health care facilities that have received affected lots are being instructed to identify the products and follow the manufacturers' return procedures.

The FDA notices provide lot numbers and other identifying information so medical facilities can determine whether products in their inventories are included in the recalls.

The Epoch Times reported that it contacted both B. Braun and Baxter for additional comment but had not received responses by the time of publication.

IV Fluid Supply Has Faced Challenges Before

The Baxter recall comes against the backdrop of previous disruptions to the U.S. IV fluid supply.

In 2024, Baxter's manufacturing facility in North Cove, North Carolina, was damaged by Hurricane Helene. The resulting disruption contributed to shortages of IV fluids across the country.

At the time, Baxter said the North Carolina facility accounted for approximately 60 percent of the U.S. supply of IV fluids, highlighting the importance of major manufacturing facilities to the nation's medical supply chain.

The effects of the shortage continued into 2025. In August of that year, the FDA announced that the nationwide shortage of 0.9 percent sodium chloride injection products had ended. The agency also said it was continuing to work with manufacturers regarding shortages involving other IV fluid products.

The latest recalls therefore come at a time when hospitals and health care providers remain attentive to the reliability and safety of essential injectable medical products.

What Patients and Health Care Providers Should Know

The recalls specifically concern identified lots rather than every sodium chloride IV product manufactured by B. Braun or Baxter.

Health care facilities should therefore compare products in their inventory against the lot numbers listed in the FDA recall notices before using them.

Patients who receive IV fluids in hospitals or other medical settings generally do not need to take action based solely on these announcements. Medical facilities are responsible for checking their supplies and following recall instructions.

Sodium chloride IV solutions have a wide range of medical uses, particularly for patients who cannot adequately consume fluids or nutrients by mouth. However, like other medical treatments, their use depends on the patient's individual circumstances.

FDA-approved labeling available through DailyMed notes that sodium chloride infusion should not be administered in certain situations, including congestive heart failure and severe renal insufficiency, as well as conditions involving sodium retention accompanied by edema.

The current recalls serve as a reminder that even widely used medical products require careful quality control throughout manufacturing, distribution, storage, and administration.

For the latest product details, affected lot numbers, and instructions for health care facilities, readers should consult the official FDA recall notices and the manufacturers' instructions rather than relying on secondary reports.

Source: U.S. Food and Drug Administration recall notices published Aug. 26 and Aug. 28, 2026.