Recall Summary
| Recall number | Z-2388-2026 |
| Issued by | U.S. Food and Drug Administration |
| Date | 2026-06-24 |
| Company | ARROW INTERNATIONAL, LLC |
| Units affected | 62,719 |
| 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 began reaching hospitals and dialysis clinics in June 2026. Arrow International, LLC recalled a group of hemodialysis kits and catheter sets. The U.S. Food and Drug Administration classified this action as Class I. That is the agency’s most serious recall category. The concern involves injectable drugs packed inside these medical kits. This guide explains the arrow international recall in plain, calm language. It matters because these products support life-sustaining dialysis care. Read on to learn what was affected and what to do next.
What the Arrow International Recall Covers
The arrow international recall covers hemodialysis kits and acute hemodialysis catheter kits. These are often labeled as AHDC kits in clinical settings. The affected products include several sizes and lumen configurations. For example, the list includes a 2-lumen 12 Fr x 20 cm hemodialysis kit. It also includes 3-lumen 12 Fr kits in 16 cm and 20 cm lengths.
The FDA record lists specific reference (REF) numbers for the recalled items. These include AK-15122-F, ASK-12123-UOC1, and ASK-12123-UPM. They also include ASK-15123-UOC1, ASK-15123-UPM, and CDC-12123-P1A. The agency record shows additional 3-lumen configurations beyond this list. As a result, staff should check the full official notice for every REF code.
The FDA assigned this action recall number Z-2388-2026. The recall was dated June 24, 2026. In total, 62,719 units fall within the scope. Because these kits ship to healthcare facilities, most consumers will not have them at home. Typically, dialysis centers and hospital pharmacies are the ones holding this inventory.
Identifying the affected stock is the first practical step. However, the safest method is matching REF numbers against the official list. The arrow international recall applies to the exact catalog codes named by the FDA. If a code is not on that list, it is not part of this action.
The Hazard and Reported Injuries
The hazard in the arrow international recall does not come from the catheters themselves. Instead, it comes from injectable drugs included inside the kits. These drugs are lidocaine, bupivacaine, and 0.9% sodium chloride. They were the subject of a separate supplier recall. That supplier was found to have quality issues.
The FDA also noted limited reports of drug ineffectiveness tied to the supplier. More seriously, the sterility of these water-based injectables may be compromised. If sterility fails in an injectable product, the risk rises sharply. In most cases, compromised sterility can lead to serious or life-threatening injuries. For this reason, the FDA gave the arrow international recall a Class I rating.
It is important to be precise about harm here. The FDA record does not state whether any injuries have actually occurred. As a result, this guide does not claim that injuries happened or that they did not. The Class I label describes potential risk, not a confirmed outcome. Typically, Class I means a reasonable probability of serious harm exists.
| Recall number | Z-2388-2026 |
|---|---|
| Issuing agency | U.S. Food and Drug Administration |
| Recall date | June 24, 2026 |
| Company | Arrow International, LLC |
| Units affected | 62,719 |
| Severity classification | Class I |
What To Do If You Own This Product
If your facility stocks these kits, act carefully and methodically. First, stop using any product that matches the recalled REF numbers. Then, quarantine that inventory so no one uses it by mistake. However, do not discard anything until you confirm the correct process. The arrow international recall notice explains how affected stock should be handled.
Next, identify the products accurately before taking further action. Check each kit’s REF code against the FDA’s official list. Match lot or catalog details exactly, not by name alone. For example, two similar kits may differ by a single code suffix. In most cases, your supply or pharmacy team can help verify codes.
The specific remedy for this arrow international recall is not restated here. The agency record contained remedy text that did not match the product. Because of that mismatch, the remedy details have been withheld from this guide. Instead, follow the instructions in the official notice linked on this page. That notice is the authoritative source for return, replacement, or correction steps.
Finally, contact the right parties for confirmation and support. Reach out to Arrow International or your product distributor with your REF numbers. You can also review the FDA’s official notice for direct guidance. Read the official FDA recall notice here. Keep written records of every step you take.
Does a Arrow International Recall Mean You Can Sue?
A recall and a lawsuit are not the same thing. The arrow international recall is a safety action, not a legal claim. The FDA uses recalls to remove risky products from use. However, a recall by itself does not create a right to sue. It is a warning and a correction, nothing more.
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A legal claim usually requires more than a recall notice. Typically, you need an actual injury linked to the product. You also need to show causation between the product and that harm. In most cases, these are difficult questions that depend on medical facts. As a result, a recall is only one piece of any potential case.
This guide does not promise any outcome or payment. It does not claim a lawsuit exists over this arrow international recall. If you believe you were harmed, you may be eligible to seek advice. However, only a licensed attorney can evaluate your specific situation. Speak with a qualified lawyer before drawing any conclusions.
How Recalls Connect to Mass Tort Cases
Recalls sometimes become part of larger legal stories later. A recall can serve as documented evidence that a defect existed. For example, the Philips CPAP recall preceded extensive product litigation. Plaintiffs there pointed to the recall as one factual anchor. However, the recall alone did not decide those cases.
The Takata airbag recall followed a similar broad pattern. It grew into one of the largest safety actions in history. Later, that recall featured in many injury and consumer claims. Still, each claim required its own proof of harm and causation. So a recall can matter in a mass tort, but it never guarantees one.
Frequently Asked Questions
Is the arrow international recall a Class I recall?
Yes. The FDA classified it as Class I, its most serious category. That label reflects a potential risk of serious or life-threatening harm.
How many units are covered by this recall?
The FDA record lists 62,719 units in the scope. The action carries recall number Z-2388-2026 and was dated June 24, 2026.
What should I do if my clinic has these kits?
Stop using any matching products and set them aside safely. Then follow the instructions in the official FDA notice linked above 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.