Recall Summary
| Recall number | Z-2377-2026 |
| Issued by | U.S. Food and Drug Administration |
| Date | 2026-06-24 |
| Company | ARROW INTERNATIONAL, LLC |
| Units affected | 126,530 |
| 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
arrow international recall notices reached hospitals across the country in June 2026. The U.S. Food and Drug Administration classified this action as Class I. That is the agency’s most serious category. The recall involves Arrow International, LLC, a maker of catheter kits and vascular access trays. Certain kits contained recalled injectable drugs from a supplier. If you or a loved one received care using these kits, this guide explains what happened. It also explains what the recall does and does not mean for you.
What the Arrow International Recall Covers
The arrow international recall covers a range of medical catheter kits and trays. These are professional products used in clinical settings. They are not sold to consumers in stores. Instead, hospitals and surgical centers stock them. The FDA assigned this action recall number Z-2377-2026. The agency recorded the recall date as June 24, 2026.
The affected products carry specific reference codes. For example, the list includes the “ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6” and the “RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-X1.” It also lists an “ASP ACCESS TRAY/ASK-04001-MS” and a “RA CATH KIT: 20 GA X 8 CM/ASK-00820-UM1.” Other items include a “VESSEL CATH KIT: 20GA X 5IN/AK-04550-S” and several central venous catheter kits. Among them are a “CVC KIT: 1-LUMEN 5 FR X 20 CM/AK-04301-SP” and a “CVC KIT: 16 GA X 6IN (16 CM)/AK-04306-SP.”
The scope is large. In total, the recall affects 126,530 units. These kits were distributed to healthcare facilities, not directly to patients. As a result, most people would not have handled these products themselves. Typically, a doctor or nurse uses the kit during a procedure. The arrow international recall therefore matters most to clinicians and the patients they treat.
If you are a patient, you likely will not have a kit at home. However, you may have received care that involved one. Facilities are responsible for checking their inventory. In most cases, hospitals track lot numbers and reference codes closely. Ask your provider if you have concerns about a recent procedure.
The Hazard and Reported Injuries
The hazard in this arrow international recall traces back to a supplier problem. The kits and sets contained lidocaine, bupivacaine, and 0.9% sodium chloride. These are injectable products used during medical procedures. The drugs themselves were the subject of a separate supplier recall. That supplier was found to have quality issues.
The FDA record notes limited reports of drug ineffectiveness tied to the supplier. There is a further concern about sterility. If the sterility of a water-based injectable product is compromised, the risk rises sharply. According to the agency, this could lead to serious or life-threatening injuries. That risk is why the FDA labeled this a Class I recall.
It is important to be precise here. The agency record does not state whether any injuries have actually happened. As a result, this guide will not claim that injuries occurred. It also will not claim that none did. The record simply describes the potential for harm. For example, a compromised injectable could carry infection risk. That is the safety worry the recall is meant to address.
| Recall number | Z-2377-2026 |
|---|---|
| Issuing agency | U.S. Food and Drug Administration |
| Recall date | June 24, 2026 |
| Company | Arrow International, LLC |
| Units affected | 126,530 |
| Severity classification | Class I |
What To Do If You Own This Product
First, understand that these are professional kits. Consumers do not usually stock them. However, some clinics, home-care providers, or facilities may hold inventory. If you manage such supplies, stop using the affected kits now. Set them aside so no one uses them by mistake.
Next, identify the products by their reference codes. The arrow international recall list includes codes like ASK-04510-MM6 and AK-04306-SP. Compare your stock against the full list in the official notice. For example, check both the kit label and any inner packaging. Typically, the reference number appears near the product description. Isolate any matching items right away.
Then follow the official instructions for the remedy. The agency record for this recall contains remedy text that does not match the product. Because of that mismatch, the remedy has been withheld here. So do not rely on secondhand descriptions of what to do next. Instead, follow the instructions in the official notice linked on this page. That notice is the authoritative source for the correct steps.
You can review the official FDA record for full details. Read it here: FDA Enforcement Report for the Arrow International recall. If you are a patient, talk to your care team. Ask whether any product from this recall was used during your treatment. In most cases, your facility can look this up quickly.
Does a Arrow International Recall Mean You Can Sue?
This is a common and fair question. A recall is a safety action. It is not a lawsuit. The arrow international recall is the FDA and the company working to remove risk. By itself, a recall does not create a legal claim. It also does not prove that anyone was harmed.
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Legal claims usually require more than a recall notice. Typically, a person must show a real injury. They must also show that a specific product caused that injury. That link is called causation. Without injury and causation, a recall alone is not a claim. As a result, many recalls end without any litigation at all.
That said, some people do experience harm from recalled products. If that describes you, your situation may be different. You may be eligible to explore your options. However, no one can promise a result. Every case depends on its own facts and evidence.
For personalized advice, speak with a licensed attorney. A qualified lawyer can review your medical records. They can assess whether the arrow international recall connects to any harm you suffered. This guide does not offer legal advice. It also does not guarantee any outcome or compensation.
How Recalls Connect to Mass Tort Cases
Recalls and mass torts are separate things. However, they sometimes overlap over time. A recall can become a piece of evidence later. For example, it may show that a company knew about a defect. In some past cases, that documentation shaped litigation. The Philips CPAP recall is one well-known example. Many device recalls draw public and legal attention.
Another historical example is the Takata airbag recall. That recall grew into one of the largest safety actions ever. Over time, injured people pursued claims related to those airbags. Still, each of those situations was unique. A recall did not automatically mean anyone won a case. The arrow international recall has no such litigation established in the record. Do not assume a lawsuit exists here, because none is confirmed.
Frequently Asked Questions
Is the Arrow International recall dangerous?
The FDA rated it Class I, its most serious level. That means there is a reasonable chance of serious or life-threatening harm. The record does not confirm whether any injuries occurred. Follow the official notice for guidance.
What should I do if I have an affected kit?
Stop using it right away. Check the reference codes against the official FDA list. Then follow the remedy instructions in the linked official notice. Do not guess at the correct steps.
Can I file a lawsuit because of this recall?
A recall by itself is not a lawsuit. You would generally need a real injury and proof it was caused by the product. Speak with a licensed attorney to review your specific situation. 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 July 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.