Recall Summary
| Recall number | Z-2384-2026 |
| Issued by | U.S. Food and Drug Administration |
| Date | 2026-06-24 |
| Company | ARROW INTERNATIONAL, LLC |
| Units affected | 1,061,069 |
| 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 the action as Class I. That is the agency’s most serious category. Arrow International, LLC recalled a large group of procedure trays, kits, and sets. These products contained lidocaine, bupivacaine, and 0.9% sodium chloride from an outside supplier.
That supplier was recalled separately for quality problems. As a result, more than a million units are affected. If you had a catheter placed or a procedure done recently, this may matter to you.
What the Arrow International Recall Covers
The arrow international recall covers medical kits and trays, not consumer products. These are professional-use items. Hospitals, surgery centers, and clinics buy them. Patients almost never handle them directly. The FDA assigned the action recall number Z-2384-2026 and dated it June 24, 2026.
The agency record lists specific product descriptions and REF numbers. They include ACCESS TRAY/ASK-04001-JHH and ACCESS TRAY/ASK-04001-LMDTG. The list also includes PI CVC KIT: 3 LUMEN 7 FR X 6 IN (16 CM)/ASK-12703-PSPH1. Another entry is 3L CVC KIT: 7 FR X 16 CM/ASK-12703-WMC2. Two more are MULTILUMEN PI CVC KIT: 3L 7 FR X 20CM/ASK-15703-LMDT1 and MULTILUMEN PI CVC KIT: 3L 7 FR X 20CM/ASK-15703-LMDTG1. The record continues with additional multilumen PI CVC items.
CVC stands for central venous catheter. These kits are used to place a line into a large vein. Typically that happens in an operating room, an ICU, or an emergency department. The kits bundle the catheter with other supplies. Those supplies include the injectable drugs at the center of this arrow international recall.
The scope is large. The FDA lists 1,061,069 units. However, the agency record does not publish a full lot-by-lot list in the summary entry. For example, a hospital pharmacy would need the official notice to match specific lot numbers on hand. The official FDA notice linked on this page is the place to confirm exact affected inventory.
The Hazard and Reported Injuries
The hazard is not the catheter itself. It is the drugs packed inside the kits. Lidocaine, bupivacaine, and 0.9% sodium chloride were the subject of a supplier recall. The supplier was found to have quality issues. There were also limited reports of drug ineffectiveness.
Two separate risks follow from that. The first is ineffectiveness. Lidocaine and bupivacaine are local anesthetics. If they do not work as expected, a patient may feel pain during a procedure. In most cases a clinician would notice and respond.
The second risk is more serious. These are water-based injectable products. If sterility is compromised, contamination can enter the bloodstream directly. According to the FDA, that could lead to serious or life-threatening injuries. That risk is why the agency classified this as Class I rather than a lower tier.
The agency record does not state whether injuries have been reported in connection with this arrow international recall. This guide does not claim any occurred. It also does not claim none occurred. A Class I classification describes the potential for harm. It is not a count of actual harm.
| Recall number | Z-2384-2026 |
|---|---|
| Issuing agency | U.S. Food and Drug Administration |
| Recall date | June 24, 2026 |
| Company | ARROW INTERNATIONAL, LLC |
| Units affected | 1,061,069 |
| Severity classification | Class I |
What To Do If You Own This Product
Most readers will not have these kits at home. They are hospital supplies. However, some home infusion providers, dialysis programs, and clinics do stock them. If you manage inventory anywhere, check your shelves now.
Start by identifying the product. Look at the REF number printed on the tray or kit label. Compare it against the descriptions listed above. Also record the lot number. Typically the lot appears near the REF on the same label panel.
Do not use any product you believe is affected. Set it aside and label it clearly. As a result, no one on your team will grab it by mistake. Then follow the instructions in the official FDA notice linked on this page. This guide does not state what the remedy is, because the agency record for this recall contains remedy text that does not match the product. The official notice is the authority on next steps.
Patients have a different task. You cannot inspect a kit used weeks ago. Instead, contact the facility where your procedure took place. Ask whether affected lots were in use on your date of service. For example, ask specifically about central line placement or local anesthetic injections. If you have new symptoms such as fever, chills, or redness near a catheter site, seek medical care promptly. Keep copies of your records. You can read the official notice here: FDA medical device recall database
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Does a Arrow International Recall Mean You Can Sue?
No. A recall is a safety action, not a lawsuit. This point is worth stating plainly. The FDA classifies recalls to warn the public and get unsafe products out of use. A recall notice is not a legal claim, and it does not create one on its own.
An injury claim generally requires more than a recall. Typically you need an actual injury. You also need a link between the product and that injury. Lawyers call that causation. In most cases, proving causation requires medical records, expert review, and product identification.
That last part matters here. These kits are used inside hospitals. A patient may not know which brand or lot was used. Facility records often hold that information. As a result, obtaining your complete medical chart is usually the first practical step.
If you believe you were harmed, you may be eligible to pursue a claim. However, no one can promise an outcome, and no compensation is guaranteed. Deadlines called statutes of limitation also apply and vary by state. Speak with a licensed attorney in your state about your specific facts. This guide is general education, not legal advice.
How Recalls Connect to Mass Tort Cases
Recalls and lawsuits are separate, but they sometimes intersect. A recall notice can become a document in later litigation. It can show what a company knew and when it acted. Plaintiffs’ lawyers often point to recall timing. Defense lawyers often point to the recall as evidence of responsible action. Neither view is automatic, and courts decide what the record actually shows.
History offers real examples. Philips recalled millions of CPAP and BiPAP machines in 2021 over sound abatement foam degradation. Thousands of lawsuits followed and were consolidated into multidistrict litigation. Takata airbag inflators were recalled across many automakers in one of the largest automotive recalls ever recorded. That, too, drew extensive litigation. However, neither example predicts anything about the arrow international recall. Each product, each record, and each injury is judged on its own facts.
Frequently Asked Questions
What does Class I mean in the arrow international recall?
Class I is the FDA’s most serious recall category. It means there is a reasonable probability that use of the product could cause serious health consequences or death. It describes potential risk, not a confirmed injury count.
Were any injuries reported in this recall?
The FDA record for recall Z-2384-2026 does not state whether injuries have been reported. This guide will not claim either way. Check the official FDA notice for any updates the agency publishes.
Is the arrow international recall the same as a lawsuit?
No. A recall is a regulatory safety action taken to remove or correct a product. A lawsuit is a separate legal proceeding that requires an injury and proof of causation. A recall alone does not create a claim.
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 August 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.