Recall Summary
| Recall number | Z-2386-2026 |
| Issued by | U.S. Food and Drug Administration |
| Date | 2026-06-24 |
| Company | ARROW INTERNATIONAL, LLC |
| Units affected | 180 |
| 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 affect patients and clinicians who used a specific paracentesis kit. The U.S. Food and Drug Administration issued this arrow international recall in June 2026. Arrow International, LLC is the company named in the record. The action carries a Class I classification. That is the most serious level the FDA uses. It means there is a reasonable chance the product could cause serious harm. This guide explains the recall in plain, calm language for everyday readers.
What the Arrow International Recall Covers
The FDA record identifies one specific product. It is described as a “PARACENTESIS KIT” with reference code ASK-00376-JHH. A paracentesis kit is a medical device used to drain fluid from the abdomen. Clinicians rely on these kits during procedures. As a result, the reliability of every component matters a great deal.
The recall number is Z-2386-2026. The FDA logged the action on June 24, 2026. The company of record is ARROW INTERNATIONAL, LLC. In total, the scope covers 180 units. That is a limited quantity. However, the severity classification raises the stakes for each affected kit.
The agency record does not publish lot codes or sale dates in the summary reviewed here. For example, exact purchase dates are not stated. If you need those specifics, check the official notice linked on this page. In most cases, hospital purchasing or supply teams can confirm whether a facility received affected units. The arrow international recall applies only to the described kit, not to every Arrow product.
The Hazard and Reported Injuries
The hazard involves the drugs packed inside the kits and sets. Three items are named. They are Lidocaine, Bupivacaine, and 0.9% sodium chloride. These came from a supplier that was itself the subject of a recall. That supplier was found to have quality issues.
The record also notes limited reports of drug ineffectiveness tied to the supplier. That is a distinct concern from contamination. Separately, sterility is a core worry with injectable products. If the sterility of a water-based injectable product is compromised, the result can be serious. In some cases it could be life-threatening.
It is important to be precise here. The FDA record does not state whether injuries have been reported. Therefore, this guide makes no claim either way. The arrow international recall is a preventive safety action based on the identified risk. It does not, by itself, confirm that anyone was harmed.
| Detail | Information |
|---|---|
| Recall number | Z-2386-2026 |
| Issuing agency | U.S. Food and Drug Administration |
| Recall date | June 24, 2026 |
| Company | ARROW INTERNATIONAL, LLC |
| Units affected | 180 |
| Severity classification | Class I |
What To Do If You Own This Product
Start with a simple step. Stop using any kit that matches the recalled description. The product is the paracentesis kit with reference ASK-00376-JHH. Set it aside so no one uses it by mistake. Typically, facilities quarantine recalled inventory in a marked area.
Next, confirm identity carefully. Match the reference code and the product name against your stock. For example, compare the label to the details in the official notice. If you are a patient rather than a provider, you likely will not hold this kit yourself. In most cases, a hospital or clinic used it during a procedure.
Then follow the official instructions. The remedy details in this specific record could not be confirmed as matching the product. As a result, this guide will not state a remedy. Instead, follow the steps in the official FDA notice for this arrow international recall. You can read the notice here: official FDA recall notice
Finally, keep your own records. Note any procedure dates and the facility involved. Save any paperwork you received. However, do not panic. A recall is a caution, and this arrow international recall is meant to reduce risk before harm occurs. When in doubt, ask your provider to check their supply records.
Does a Arrow International Recall Mean You Can Sue?
This is a common and fair question. The short answer is no, not automatically. A recall is a safety action. It is a step taken to protect the public. A recall, on its own, is not a lawsuit and not a legal claim.
A legal claim usually needs more than a recall. Typically, it requires an actual injury. It also requires a link between that injury and the product. Lawyers call that link causation. Without both, a recall alone does not create a case. The arrow international recall does not, by itself, mean anyone can sue.
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That said, your situation may differ. For example, if you were harmed during a procedure, your facts matter. A licensed attorney can review the timeline and records. You may be eligible to pursue a claim in some circumstances. However, no one can promise an outcome or guarantee compensation.
Be careful with any source that promises money. This guide makes no such promise. It offers no legal advice. Instead, speak with a licensed attorney in your state. They can explain your rights based on the real details of your case, not general information.
How Recalls Connect to Mass Tort Cases
Recalls and lawsuits are separate things. However, they sometimes intersect over time. A recall can create a written record of a known problem. Later, that record may become evidence if injuries emerge and litigation begins. For example, the Philips CPAP recall in 2021 preceded thousands of injury claims that were grouped into coordinated litigation.
The Takata airbag recall is another well-known example. It grew into one of the largest safety actions in history. As a result, it fed into extensive litigation and settlements. These examples do not describe this arrow international recall. They simply show how a recall can matter later. For now, the record here documents a risk, and nothing more should be assumed.
Frequently Asked Questions
Is the Arrow International recall serious?
Yes, the FDA gave it a Class I classification. That is the most serious level. It means there is a reasonable chance the product could cause serious harm.
How many units are affected by this recall?
The FDA record lists 180 units. The affected product is the paracentesis kit with reference ASK-00376-JHH. Check the official notice to confirm whether specific inventory is included.
Does this recall mean I have a lawsuit?
No. A recall is a safety action, not a lawsuit. A claim generally needs an actual injury and a proven link to the product. Speak with a licensed attorney to review your specific situation.
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.