Recall Summary
| Recall number | Z-2385-2026 |
| Issued by | U.S. Food and Drug Administration |
| Date | 2026-06-24 |
| Company | ARROW INTERNATIONAL, LLC |
| Units affected | 426,041 |
| 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
The arrow international recall is a Class I safety action announced by the U.S. Food and Drug Administration. It involves procedure kits and trays made by Arrow International, LLC. These products contain injectable medications that were part of a supplier recall. Regulators consider this the most serious recall category. That means the FDA believes exposure could cause serious injury or death. If you work in a clinical setting, this notice matters to you and your patients.
What the Arrow International Recall Covers
The recall targets a range of access trays and pressure injection kits. The FDA identified them by REF numbers. For example, one is the Access Tray, REF GU-04020. Others are pressure injection kits in several French sizes. These include the 8.5 FR kit, REF AK-09803-CDC, and the 9 FR kit, REF AK-09903-CDC.
Several kits carry longer catalog codes tied to specific customers. For example, the arrow international recall lists REF ASK-09810-PCMH1 and REF ASK-09903-KH. It also names REF ASK-09903-PHP1 and REF ASK-09903-UPA. Sizes typically range around 8.5 FR to 9 FR and about 4 inches, or 10 centimeters, in length. Some codes appear truncated in the agency record.
The FDA assigned this action recall number Z-2385-2026. The recall date is June 24, 2026. In total, the scope covers 426,041 units. That is a large volume of clinical product. As a result, many hospitals and clinics may hold affected inventory. Check any Arrow-branded trays and PSI kits against the REF numbers above.
These are professional medical devices, not consumer items. In most cases, they are used during catheter or vascular access procedures. Typically, a clinician opens a sterile kit at the point of care. Because the products ship widely, the arrow international recall may reach facilities across the country. Confirm the exact codes before assuming a kit is affected.
The Hazard and Reported Injuries
The hazard comes from the medications inside the kits. Lidocaine, bupivacaine, and 0.9% sodium chloride were included in these sets. Those ingredients were the subject of a separate supplier recall. The supplier was found to have quality issues. There were also limited reports of drug ineffectiveness.
The deeper concern involves sterility. These are water-based injectable products. If sterility is compromised, the risk rises sharply. However, the FDA warns this could lead to serious or life-threatening injuries. That is why the agency placed this in Class I. It is the most serious classification the FDA uses.
The agency record does not state whether any injuries have occurred. As a result, we cannot say that harm happened. We also cannot say that no harm happened. The record simply does not address it. We will not guess in either direction. That is the honest and compliance-safe answer.
The table below summarizes the core facts of the arrow international recall. It reflects the verified FDA record only. Use it as a quick reference when checking inventory. For example, staff can match the recall number to internal purchase logs.
| Recall number | Z-2385-2026 |
|---|---|
| Issuing agency | U.S. Food and Drug Administration |
| Recall date | June 24, 2026 |
| Company | Arrow International, LLC |
| Units affected | 426,041 |
| Severity | Class I (most serious) |
What To Do If You Own This Product
First, stop using any kit that matches the recalled REF numbers. Set it aside so no one grabs it by accident. Label it clearly as recalled. In most cases, facilities should quarantine affected stock right away. This keeps a recalled kit from reaching a patient.
Next, identify the product carefully. Check the outer box and the kit label for the REF code. Compare it to the list tied to the arrow international recall above. For example, look for GU-04020, AK-09803-CDC, or the ASK-09903 series. Record the lot and quantity for your records.
The specific remedy instructions are not restated here on purpose. The agency remedy text in the public record does not match this product. Because of that mismatch, we are withholding it to avoid giving you wrong guidance. Instead, follow the instructions in the official notice linked on this page. That notice is the authoritative source.
Then, contact the right people. Clinical staff should notify their supply chain or risk management team. Facilities can also reach Arrow International through the channels in the official notice. If you have a health concern after a procedure, contact your clinician. Typically, your provider can advise on next steps and monitoring.
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Does a Arrow International Recall Mean You Can Sue?
A recall is a safety action. It is not a lawsuit. The arrow international recall means the FDA and the company are removing risky product from use. That step protects patients. However, it does not by itself create a legal claim for anyone.
A lawsuit usually needs more than a recall notice. Typically, it requires an actual injury. It also requires a link between that injury and the product. Lawyers call that link causation. Without both parts, a recall alone is not a claim. We are not aware of any lawsuit over this specific recall.
If you believe a recalled product harmed you, get advice from a licensed attorney. An attorney can review your records and the facts. You may be eligible to pursue a claim in some situations. However, no one can promise a result. Outcomes depend on evidence, law, and the specific details of your case.
How Recalls Connect to Mass Tort Cases
Recalls and mass torts are different, but they can overlap. A recall documents that a product had a defect or risk. Later, if many people are hurt by the same product, lawsuits may follow. In those cases, the recall record can become useful evidence. It helps show what the company knew and when.
History offers clear examples. For example, the Philips CPAP recall preceded large-scale litigation over foam breakdown. The Takata airbag recall also grew into major mass tort and criminal action. In both cases, the recall came first, and lawsuits followed. Still, a recall by itself never guarantees a case. Each claim rises or falls on its own facts.
Frequently Asked Questions
Is the arrow international recall a Class I recall?
Yes. The FDA classified it as Class I. That is the most serious category. It means exposure could cause serious injury or death.
How many units are affected?
The recall covers 426,041 units. The FDA assigned recall number Z-2385-2026. The recall date is June 24, 2026.
Where can I find the official remedy instructions?
Follow the official FDA notice linked on this page. We withheld the remedy text because the agency record did not match this product. The linked notice is the authoritative source for next steps.
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.