B. Braun Saline Recall: 3 IV Lots Recalled Nationwide Over Zinc Oxide Particles
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If you or someone you care for recently received IV fluids at a hospital, infusion center, or other healthcare facility, there is a new nationwide saline recall worth knowing about.
B. Braun Medical Inc. is recalling three lots of 0.9% Sodium Chloride Injection USP after particulate matter identified as zinc oxide was found in the solution. The recalled saline was distributed nationwide to hospitals and healthcare facilities from February 27 through August 3, 2026.
This is not a recall of every B. Braun saline product, and it is not the type of saline most people buy off a retail shelf. The recall involves one specific 100 mL IV product and three specific lot numbers.
Here is exactly what is affected, why the particles matter, and what patients and healthcare facilities should do next.
B. Braun Saline Recall at a Glance
Product: B. Braun 0.9% Sodium Chloride Injection USP
Size: 100 mL in a 150 mL PAB container
Catalog number: S8004-5264
NDC: 0264-1800-32
Affected lots: J6B435, J6B444, J6B457
Expiration date: April 30, 2027
Recall reason: Particulate matter identified as zinc oxide
Distribution: Hospitals and healthcare facilities nationwide
Distribution dates: February 27 through August 3, 2026
FDA publish date: August 28, 2026
Reported serious injuries or deaths: None reported when the recall was announced
What Happened With the B. Braun Saline Recall?
B. Braun Medical voluntarily recalled three lots of its 0.9% Sodium Chloride Injection USP because particulate matter was found in the IV solution. According to the FDA notice, the particles were identified as zinc oxide.
The product is used in adults and children as a source of electrolytes and water for hydration. It can also be used as a diluent and delivery system for compatible medications administered intravenously.
That last part is important. This solution is delivered directly into the body through an IV, which is why visible or microscopic foreign particles in the solution can present a more serious concern than a defect in an ordinary consumer product.
The FDA lists the company announcement date as August 27, 2026 and published the recall on August 28. The body of the company announcement reproduced by FDA is dated August 19. For consumers, the key point is that the recall is now publicly posted by FDA and covers the three lots listed below.
Which B. Braun Saline Lots Are Recalled?
Do not assume every bag or container of B. Braun saline is affected. The current FDA announcement identifies one product and three lots.
Check for all of the following product details:
Product: 0.9% Sodium Chloride Injection USP
Fill volume: 100 mL
Container: 150 mL PAB container
Catalog number: S8004-5264
NDC: 0264-1800-32
Expiration: April 30, 2027
The recalled lot numbers are:
J6B435
J6B444
J6B457
If the lot number does not match one of these three numbers, it is not included in this specific recall based on the FDA announcement available on August 28, 2026.
This distinction matters because B. Braun manufactures multiple IV products, and there have been other B. Braun recalls involving different products and lot numbers. Checking the exact product, NDC, catalog number, lot number, and expiration date is more reliable than checking the brand name alone.
Why Is the Saline Being Recalled?
The FDA says the recall was initiated because of particulate matter identified as zinc oxide in the solution.
Particulate matter means unwanted material is present in a product that should meet strict standards for intravenous use. When a solution is infused directly into the bloodstream, foreign particles can potentially travel through blood vessels rather than passing through the digestive system.
That is why the FDA recall notice describes potentially serious outcomes if particulate-contaminated solution is administered.
What Are the Potential Health Risks?
According to the FDA-posted recall announcement, particles infused into the circulatory system can potentially cause pulmonary emboli, which are blockages in blood vessels in the lungs. Particles may also obstruct other blood vessels, potentially leading to tissue damage or organ injury.
Other potential complications described in the recall information include phlebitis, clotting, systemic immune activation, organ dysfunction, and hemolysis, which is the breakdown of red blood cells.
Those are potential risks associated with particulate contamination. They do not mean that patients who previously received B. Braun saline experienced these problems.
At the time of the announcement, B. Braun reported no serious injuries, deaths, or other adverse events associated with this issue.
Where Was the Recalled B. Braun Saline Distributed?
The affected saline was distributed nationwide to hospitals and healthcare facilities between February 27 and August 3, 2026.
The FDA announcement does not provide a public list of individual hospitals or healthcare facilities that received the recalled lots. Because of that, it would be inaccurate to assume a particular hospital used the affected product simply because it uses B. Braun supplies.
If you received IV treatment during that period and are concerned, the healthcare facility where you were treated is in the best position to determine which product and lot was used.
What Should Healthcare Facilities Do?
B. Braun says it is notifying distributors and customers by mail and arranging for recalled products to be returned and replaced.
Facilities that find one of the affected lots should follow B. Braun’s recall instructions and remove the product from use. The FDA announcement instructs customers with recalled product to return it to the place of purchase.
For healthcare workers, the fastest identification check is to compare the package against the catalog number S8004-5264, NDC 0264-1800-32, expiration date April 30, 2027, and one of the three affected lot numbers.
What Should Patients Do If They Recently Received an IV?
First, receiving an IV does not mean you received recalled B. Braun saline.
Hospitals use many IV solutions, sizes, manufacturers, and lot numbers. This recall applies only to the specific B. Braun product identified above.
If you are concerned about a recent IV treatment, you can contact the hospital, infusion center, clinic, or other healthcare facility where you received care and ask whether the recalled product was used.
If you experienced an unexpected medical problem that you think may be related to the product, the FDA notice advises consumers to contact their physician or healthcare provider.
Do not make changes to prescribed treatment based only on a recall headline. Your healthcare provider can help determine whether the recall is relevant to your care and whether any follow-up is appropriate.
How to Identify the Recalled Product
If you are a healthcare professional or have access to the original product information, do not rely on appearance alone. Match the identifying information on the package.
The four details I would check first are:
1. Lot number: J6B435, J6B444, or J6B457
2. NDC: 0264-1800-32
3. Catalog number: S8004-5264
4. Expiration date: April 30, 2027
The FDA recall page also includes an official product photo. For product identification, use the FDA image rather than an AI-generated recreation of the package.
Is This the Same as Other Recent IV Fluid Recalls?
No. There have been several IV solution recalls, so it is easy to see a headline about saline and assume they are all part of the same event.
For example, Baxter also announced a separate August 2026 recall involving two lots of 0.9% Sodium Chloride Injection because of potential fiberglass particulate matter. That is a different manufacturer, different product size, and different recall.
B. Braun has also had previous recalls involving other IV solutions and particulate matter. Each recall needs to be checked by exact product and lot information rather than by the words “saline recall” alone.
This is one reason we maintain the Your First 10 Recall Center. You can see our latest verified recall coverage at https://yourfirst10.com/category/recalls/ instead of trying to sort through unrelated recall headlines.
Frequently Asked Questions
Is all B. Braun saline recalled?
No. The August 28 FDA announcement covers B. Braun 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB container with catalog number S8004-5264, NDC 0264-1800-32, and lot numbers J6B435, J6B444, and J6B457.
What was found in the recalled saline?
The FDA says the particulate matter was identified as zinc oxide.
Was the recalled saline sold at Walmart, CVS, Walgreens, or other retail stores?
The FDA announcement says the product was distributed nationwide to hospitals and healthcare facilities. It does not identify ordinary retail stores as the distribution channel for this recall.
Were any injuries reported?
No serious injuries, deaths, or other adverse events associated with the issue had been reported when the recall was announced.
What if I received an IV between February and August 2026?
That date range alone does not mean you received recalled saline. If you are concerned, contact the healthcare facility where you received treatment and ask whether the specific B. Braun product and affected lot were used.
Can I report a problem to the FDA?
Yes. The FDA recall announcement directs patients and healthcare professionals to the FDA MedWatch Adverse Event Reporting program for adverse reactions or product quality problems.
The Bottom Line
If you recently received IV treatment, there is no reason to assume you were exposed to this recalled product. The B. Braun saline recall is limited to three lots of a specific 100 mL 0.9% Sodium Chloride Injection product.
The numbers that matter are J6B435, J6B444, and J6B457, with NDC 0264-1800-32, catalog number S8004-5264, and an expiration date of April 30, 2027.
Healthcare facilities should remove affected product and follow the company’s return instructions. Patients who are concerned about a recent treatment or an unexpected medical problem should contact their healthcare provider or the facility where the IV was administered.
We track new and updated recalls in the Your First 10 Recall Center . You can also read our recent Outshine Fruit Bars recall at and our Morphine Injection recall guide at .
Official Sources
U.S. Food and Drug Administration: B. Braun Medical Inc. voluntary nationwide recall of 0.9% Sodium Chloride Injection USP
Article Information
Published: August 28, 2026
Last updated: August 28, 2026
Reviewed by: Vernon Brown
Verification status: Verified against the FDA recall announcement available August 28, 2026.
This article is for informational purposes and is not medical advice. Contact a qualified healthcare professional with questions about your individual medical care.
