Recall Summary
| Recall number | Z-2371-2026 |
| Issued by | U.S. Food and Drug Administration |
| Date | 2026-06-24 |
| Company | ARROW INTERNATIONAL, LLC |
| Units affected | 1,525,831 |
| 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 and surgery centers across the country in mid-2026. The U.S. Food and Drug Administration flagged a large group of epidural catheter kits and related anesthesia products. These kits contained medications tied to a separate supplier recall. The concern centers on drug quality and sterility. For patients who received epidural or spinal anesthesia, this news feels alarming. This guide explains the arrow international recall in plain language. It covers what was recalled, why, and what you can do next.
What the Arrow International Recall Covers
The arrow international recall involves Arrow International, LLC. The FDA assigned it recall number Z-2371-2026. The agency dated the action June 24, 2026. The recall targets epidural catheter and catheterization kits. It also reaches certain spinal anesthesia and epidural sets. These are professional medical products. Typically, clinicians use them in hospitals, not homes.
Specific product codes appear in the FDA record. For example, the list includes REF ASK-05502-VM1, an epidural catheter kit rated 19 GA x 90 cm. It also names AK-05501, AK-05502, AK-05502D, AK-05503, and AK-05503-L. These are epidural catheterization kits. The arrow international recall reaches a large volume of these items across many lot codes.
The scope is substantial. In total, the recall covers 1,525,831 units. That figure reflects kits and sets, not individual patients. Because these are clinical supplies, most consumers never handle them directly. However, patients still deserve clear information. If you had a procedure using one of these kits, the arrow international recall may matter to you.
The Hazard and Reported Injuries
The core problem is not the catheter itself. Instead, it involves medications packed inside the kits. Lidocaine, bupivacaine, and 0.9% sodium chloride were included in these sets. Those items came from a supplier that faced its own recall. As a result, the FDA treated the finished kits as affected too.
The FDA describes two concerns. First, the supplier had quality issues. There were limited reports of drug ineffectiveness. Second, sterility could be compromised. These are water-based injectable products. If sterility fails, the risk rises sharply. In most cases, injectable sterility problems can lead to serious or life-threatening injury.
This recall carries a Class I severity classification. That is the FDA’s most serious category. It signals a reasonable chance of serious harm or death. The agency record does not state whether any injuries have actually occurred. Therefore, we make no claim either way. The arrow international recall reflects risk, not a confirmed injury count.
| Recall number | Z-2371-2026 |
|---|---|
| Issuing agency | U.S. Food and Drug Administration |
| Date | June 24, 2026 |
| Company | Arrow International, LLC |
| Units affected | 1,525,831 |
| Severity | Class I |
What To Do If You Own This Product
These kits are clinical supplies. Typically, patients do not store them at home. However, some clinics, mobile providers, and facilities keep inventory. If you manage such stock, act carefully. First, stop using any affected kit right away. Set it aside so no one uses it by mistake.
Next, confirm whether your product is included. Check the REF and lot codes against the FDA notice. For example, compare labels to codes like AK-05502 or AK-05503-L. Match the recall number Z-2371-2026 as well. If the details line up, treat the item as recalled. When unsure, do not use it.
The FDA record for this arrow international recall contains remedy text that does not match the product. Because of that mismatch, the remedy has been withheld here. So we will not state what the corrective action is. Instead, follow the instructions in the official notice linked on this page. That notice is the authoritative source for handling steps.
Patients can still take sensible action. If you had epidural or spinal anesthesia recently, talk to your provider. Ask whether an affected kit was used. Keep any records you have. However, do not panic. A recall is a precaution. The arrow international recall does not mean you were harmed.
Does a Arrow International Recall Mean You Can Sue?
A recall is a safety action. It is not a lawsuit. The arrow international recall is the FDA and the company managing risk. It removes or corrects products that may be unsafe. By itself, a recall does not create a legal claim. This is an important distinction to understand.
Legal claims usually require more than a recall notice. Typically, a person must show an actual injury. They must also show that a specific product caused that injury. This link is called causation. Without injury and causation, a recall alone is not a case. For example, owning a recalled kit is not the same as being hurt by one.
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If you believe you were harmed, seek qualified advice. Speak with a licensed attorney in your state. An attorney can review your records and the facts. They can explain whether you may be eligible to file a claim. However, no one can promise an outcome. Every situation is different.
Be cautious about big promises. No honest source can say you are owed money. You may be eligible to pursue a claim in some cases. That is not a guarantee. The arrow international recall does not entitle anyone to compensation on its own. Only a proper legal review can assess your options.
How Recalls Connect to Mass Tort Cases
Recalls and lawsuits are separate, yet they can overlap. A recall can become useful evidence later. It may show a company knew about a defect. It can document dates, products, and hazards. In some mass tort cases, recall records help establish a timeline. However, the recall does not decide fault by itself.
History shows this pattern. For example, the Philips CPAP recall preceded large litigation over breathing machines. The Takata airbag recall also led to sprawling injury claims. In each case, injured people, not the recall alone, drove the lawsuits. As a result, a recall often marks the start of scrutiny, not the finish. The arrow international recall may follow its own path, and only time and evidence will tell.
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 the product could cause serious injury or death.
Were any injuries reported in this recall?
The FDA record does not state whether injuries occurred. Therefore, we cannot say either way. The recall reflects a potential hazard, not a confirmed harm count.
What should I do to find the remedy?
The remedy text in the record did not match the product, so it was withheld here. Follow the instructions in the official FDA notice linked on this page. When in doubt, contact your provider or the manufacturer directly.
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.