Recall Summary
| Recall number | Z-3131-2026 |
| Issued by | U.S. Food and Drug Administration |
| Date | 2026-09-23 |
| Company | Nova Biomedical Corporation |
| Units affected | 8,939 |
| 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
Nova Biomedical recall news reached hospitals and clinics on September 23, 2026. The U.S. Food and Drug Administration posted a Class I recall for the StatStrip Glucose and B-Ketone meter, Model No. 63910. Nova Biomedical Corporation makes the device. The problem is a software defect. It can show the wrong patient’s barcode during a glucose test. As a result, a blood sugar reading could be saved to the wrong person’s record. This guide explains the recall, the risk, and what to do next.
What the Nova Biomedical Recall Covers
The nova biomedical recall covers one product line. It is the StatStrip Glucose and B-Ketone meter, Model No. 63910. The FDA describes it as a glucose test system. The agency record lists 8,939 units in the scope of the recall.
The StatStrip meter is a point-of-care device. In most cases, it is used by nurses and other clinical staff. You will typically find it in hospitals, clinics, and long-term care settings. Staff use it at the bedside to check blood glucose. Some models also measure blood ketones.
The agency record summarized here does not list specific lot codes or serial ranges. It also does not give exact distribution dates. For that reason, facilities should not guess. Instead, check the official FDA notice linked on this page. That notice is the best source for identifying affected units.
Most readers will not own this meter personally. However, patients and families still have a stake. If you or a loved one had glucose checks in a hospital, this device may have been used. Knowing about the recall can help you ask informed questions.
The Hazard and Reported Injuries
The FDA describes a software synchronization and timing issue. It affects the barcode scanning and patient data processing component. When a new barcode is scanned, the meter may keep the old one. This can include patient ID barcodes. It can also include quality control (QC) solution ID barcodes.
When the defect occurs, the prior barcode stays on the screen. The operator may not notice the mismatch. If the operator accepts the wrong patient information, the glucose result goes to the wrong patient. For example, Patient A’s reading could appear in Patient B’s chart. As a result, care decisions could rest on the wrong number.
This matters because glucose results guide treatment. Clinicians use them to dose insulin and to manage low blood sugar. A misassigned result could lead to treatment that does not fit the real patient. That is why the FDA classified this nova biomedical recall as Class I. Class I is the agency’s most serious category. It applies when a product may cause serious health problems or death.
The agency record does not state whether any injuries have been reported. This guide makes no claim either way. If new information is released, it will appear in the official FDA notice.
| Recall Number | Z-3131-2026 |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Date | September 23, 2026 |
| Company | Nova Biomedical Corporation |
| Product | StatStrip Glucose and B-Ketone meter, Model No. 63910 |
| Units Affected | 8,939 |
| Severity | Class I |
What To Do If You Own This Product
First, confirm whether your facility uses Model No. 63910. Check the label on each StatStrip Glucose and B-Ketone meter. Compare your devices with the details in the official FDA notice. Biomedical engineering or materials management teams typically handle this step.
Next, follow the instructions in the official notice linked on this page. The agency record for this nova biomedical recall contained remedy text that did not match the product. For that reason, we have not listed a remedy here. Do not rely on secondhand summaries. The official notice and the company’s direct communication are the right sources.
In the meantime, staff should stay alert during every scan. After scanning a patient ID, check that the screen shows the correct patient. Do the same after scanning a QC solution barcode. If the information does not match, do not accept it. Report the problem through your facility’s normal channels.
Patients and families can take steps too. If you had glucose testing in a hospital, you may ask about your results. You can request your medical records. You can also report any device problem to the FDA through its MedWatch program. For questions about the device itself, contact Nova Biomedical Corporation directly.
Does a Nova Biomedical Recall Mean You Can Sue?
A recall is not a lawsuit. It is a safety action. The company and the FDA use it to fix or remove a product with a known problem. The nova biomedical recall alone does not create a legal claim for anyone.
📨 Get Free Mass Tort Guides Alerts
Free · No spam · Unsubscribe anytime
A legal claim typically needs more than a recall. In most cases, a person must show they were actually harmed. They must also show the defect caused that harm. For example, someone would need evidence that a misassigned glucose result led to wrong treatment. They would then need to link that treatment to a specific injury.
We have not verified any lawsuit filed over this recall. This guide does not suggest one exists. However, if you believe you were harmed, you may want legal advice. A licensed attorney can review your records and the facts of your case.
No outcome is guaranteed. Every case depends on its own facts and the laws of your state. If you have a valid claim, you may be eligible for compensation. Only an attorney can help you understand your options. Many offer free consultations.
How Recalls Connect to Mass Tort Cases
Recalls sometimes become evidence in later litigation. A recall notice is a public record. It can show that a company and a regulator found a defect. Lawyers may also look at internal documents, complaint reports, and timelines. However, a recall does not prove that any single person was harmed by the product.
Past cases show how this can unfold. In 2021, Philips recalled millions of CPAP and BiPAP machines over foam that could break down. Lawsuits followed and were consolidated in federal court. Similarly, Takata airbag recalls led to major litigation over inflators that could rupture. In both examples, injury claims rested on proof of harm, not on the recall alone. That same principle applies to the nova biomedical recall.
Not every recall leads to a mass tort. Many end with a fix and no litigation. In most cases, it depends on the number of reported injuries and the strength of the evidence. For now, the agency record for this nova biomedical recall does not report injuries either way.
Frequently Asked Questions
What product is part of the nova biomedical recall?
The recall covers the StatStrip Glucose and B-Ketone meter, Model No. 63910. The FDA lists 8,939 units in scope. Check the official notice for identifying details.
Why is the nova biomedical recall rated Class I?
A software defect can keep a previous barcode on the screen. If staff accept it, a glucose result may go to the wrong patient. Class I is the FDA’s most serious recall category.
Can I file a lawsuit because of the nova biomedical recall?
A recall by itself is not a legal claim. You would typically need to show an injury caused by the defect. A licensed attorney can tell you if you may be eligible to pursue a claim.
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.
Related Guides
- All Product Recalls
- All Active MDL Cases
- Mass Tort Explainers
- Mass Tort Tips
- Tort Reform by State — 50-State Comparison
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.