Recall Summary
| Recall number | D-0869-2026 |
| Issued by | U.S. Food and Drug Administration |
| Date | 2026-09-16 |
| Company | B BRAUN MEDICAL INC |
| Units affected | 201,472 |
| Severity | Class I |
Remedy: Follow the instructions in the official notice linked below. The agency record for this recall did not contain remedy text we could verify against this product, so we have not reproduced it here.
Read the official U.S. Food and Drug Administration recall notice
Braun medical recall news this fall involves one of the most common fluids used in hospitals. On September 16, 2026, the U.S. Food and Drug Administration listed a Class I recall for a B. Braun Medical Inc. saline product. The product is 0.9% Sodium Chloride Injection, USP, in a 100 mL partial fill container. The reason is particulate matter found in the solution. This matters because this fluid goes directly into a patient’s vein.
What the Braun Medical Recall Covers
The Braun medical recall covers one specific saline product. According to the FDA record, it is 0.9% Sodium Chloride Injection, USP. Each unit is a 100 mL partial fill inside a 150 mL PAB container. The label reads “Sterile, Rx only” and lists B. Braun Medical Inc., Bethlehem, PA 18018 USA. The National Drug Code (NDC) is 0264-1800-32.
The recall number is D-0869-2026. The FDA record lists 201,472 units in scope. That is a large volume for a single product code. However, the agency data provided for this page does not list specific lot numbers. To confirm whether a particular unit is affected, check the official notice. Lot details, when published, typically appear there.
This is a prescription product. In most cases, it is used in hospitals, infusion centers, and clinics. A partial fill bag like this is typically used to mix and deliver IV medications. For example, a pharmacist may add an antibiotic to the bag before it is given. As a result, most patients never handle the bag themselves.
Some people do receive IV therapy at home through a home infusion service. If that applies to you, the product could be in your home. However, the agency record does not describe where the units were distributed. Ask your infusion pharmacy directly whether your supply is affected.
The Hazard and Reported Injuries
The FDA record describes the problem as “Presence of Particulate Matter.” The particles were identified as iron oxide, inorganic material, cellulose cotton fiber, or polystyrene. Iron oxide is commonly known as rust. Cellulose cotton fiber is a plant-based fiber. Polystyrene is a type of plastic. None of these belong in a sterile injectable fluid.
Injectable solutions must be essentially free of visible particles. This is because the fluid enters the bloodstream directly. In general, particles in IV fluids can cause problems. For example, they may irritate or inflame a vein. Larger particles can, in rare cases, block small blood vessels. Some particles may also trigger an immune or inflammatory reaction. These are general risks, not confirmed outcomes from this product.
The FDA rated this a Class I recall. That is the most serious recall category. It means the agency found a reasonable probability that use of the product could cause serious health problems or death. However, a Class I rating describes potential risk. It does not by itself mean anyone was harmed.
The agency record does not state whether any injuries have been reported. We will not guess either way. If you had an unusual reaction during or after an IV infusion, talk to your doctor. Your care team can review your records and the products used.
| Detail | Information |
|---|---|
| Recall Number | D-0869-2026 |
| Issuing Agency | U.S. Food and Drug Administration |
| Date | September 16, 2026 |
| Company | B BRAUN MEDICAL INC |
| Product | 0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container (NDC 0264-1800-32) |
| Units Affected | 201,472 units |
| Severity | Class I |
What To Do If You Own This Product
First, do not use any unit you suspect is affected. This applies to home infusion patients and to facilities alike. Set the product aside in a separate, labeled area. Do not throw it away until you know the proper steps. Some recall instructions ask for return of the product rather than disposal.
Next, identify the product. Look for “0.9% Sodium Chloride Injection, USP” on the label. Check for the 100 mL partial fill and 150 mL PAB container description. Then look for NDC 0264-1800-32. If all of these match, your product falls within this Braun medical recall. Lot numbers, if listed, will be in the official notice.
For the remedy, follow the instructions in the official notice. We are not listing a remedy on this page. The agency record we reviewed contained remedy text that did not match this product. As a result, we withheld it to avoid giving you wrong guidance. You can find the notice here: FDA Enforcement Report for drug recalls.
Finally, contact the right people. Home infusion patients should call their infusion pharmacy or prescribing doctor. Hospitals and clinics should contact their B. Braun representative or distributor. If you think the product caused a health problem, seek medical care first. You can also report problems to the FDA through its MedWatch program.
Does a Braun Medical Recall Mean You Can Sue?
A recall is not a lawsuit. This point is often misunderstood. A recall is a safety action. It removes or corrects a product that may pose a risk. The Braun medical recall is a step taken to protect patients. It does not create a legal claim on its own.
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A recall alone is not a claim. Typically, a product liability case needs more. You would usually need to show that you were injured. You would also need to show the product caused that injury. In most cases, medical records are the key evidence. For example, records might show which product was infused and when symptoms began.
We have not verified any lawsuit filed over this Braun medical recall. That could change over time. However, nothing in the agency record points to litigation. If you believe you were harmed, consider speaking with a licensed attorney. Many product liability lawyers offer free consultations.
An attorney can review your facts and explain your options. You may be eligible to pursue a claim if injury and causation can be shown. However, no one can guarantee an outcome. Be cautious of anyone who promises money before reviewing your records. Deadlines called statutes of limitations also apply, so timing matters.
How Recalls Connect to Mass Tort Cases
Recalls sometimes become evidence in later litigation. A recall shows that a company or regulator identified a defect. Lawyers may use recall records to show when a problem was known. For example, the 2021 Philips Respironics recall involved CPAP and ventilator devices. The foam inside some devices could break down. That recall was followed by thousands of claims, consolidated in federal court in Pennsylvania.
The Takata airbag recalls are another example. Defective inflators led to one of the largest recalls in U.S. history. Many lawsuits followed and were consolidated in federal court in Florida. However, in both cases, the claims rested on actual injuries and losses. The recall helped as evidence. It was never the claim itself.
Most recalls never lead to mass tort litigation. Many end with the product removed and no widespread harm. Whether the Braun medical recall leads anywhere legally is unknown today. As a result, the best step for now is simple. Follow the official notice and protect your health.
Frequently Asked Questions
What product is part of the Braun medical recall?
The recall covers 0.9% Sodium Chloride Injection, USP, 100 mL partial fill in a 150 mL PAB container. The NDC is 0264-1800-32. The FDA recall number is D-0869-2026.
Why was this saline product recalled?
The FDA record cites particulate matter in the solution. The particles were identified as iron oxide, inorganic material, cellulose cotton fiber, or polystyrene. The FDA classified it as a Class I recall, its most serious category.
Can I file a lawsuit because of the Braun medical recall?
A recall by itself does not support a lawsuit. If you were injured and the product likely caused it, you may be eligible to pursue a claim. A licensed attorney can review your situation, but no outcome is guaranteed.
Were You Injured by a Recalled Product?
A recall by itself is a safety action, not a legal claim. However, if a recalled product caused a real injury, you may be eligible to pursue compensation. A licensed attorney can review your situation at no upfront cost — most work on contingency, meaning you pay nothing unless you recover.
Official Sources & Resources
Verify every recall against the issuing agency before acting:
- U.S. Food and Drug Administration: official recall database — the record of truth for this notice
- CPSC: cpsc.gov — household goods, toys, furniture, appliances
- FDA: fda.gov — food, drugs, and medical devices
- NHTSA: nhtsa.gov — vehicles, tires, and child car seats
- USDA FSIS: fsis.usda.gov — meat, poultry, and egg products
Content last reviewed October 2026. This is general educational information, not legal advice. If you notice outdated information, please contact us.
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Attorney Advertising. The information on this page is provided for general informational purposes only and does not constitute legal advice. A product recall is a safety action by a manufacturer or regulator and does not by itself establish liability or create a legal claim. No attorney-client relationship is created by accessing or using this content. Every case is unique. If you believe you were harmed by a recalled product, consult a licensed attorney in your jurisdiction.