Halyard convenience kits containing recalled Medline Recall: What To Do

Recall Summary

Recall number Z-2797-2026
Issued by U.S. Food and Drug Administration
Date 2026-08-12
Company AVID Medical, Inc.
Units affected 5,168
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 avid medical recall announced in August 2026 involves surgical convenience kits used in hospital angiography suites. The U.S. Food and Drug Administration classified this action as Class I. That is the agency’s most serious recall category. AVID Medical, Inc. is recalling Halyard convenience kits that contain recalled Medline Namic Angiographic Star Off Handle Manifolds.

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The concern is particulate matter inside the fluid path of those manifolds. Because these kits are used during procedures that access blood vessels, the risk reaches patients directly. This guide explains what was recalled, what the hazard means, and what steps to take next.

What the Avid Medical Recall Covers

The avid medical recall applies to Halyard convenience kits distributed by AVID Medical, Inc. These are pre-assembled procedure kits. Hospitals use them to save time during catheterization and imaging procedures. Each kit bundles multiple single-use components into one sterile package. The recalled kits contain a specific component that failed quality standards.

The agency record identifies the affected product as SAMMC ANGIOGRAPHY, product code SAMM066-15. That code is the key identifier for facilities checking inventory. The FDA assigned this action recall number Z-2797-2026. The recall date on the record is August 12, 2026. In total, 5,168 units fall within the recall scope.

The problem component is the Medline Namic Angiographic Star Off Handle Manifold. Medline recalled that manifold at the manufacturer level. As a result, every downstream kit containing the part was pulled as well. This is a common pattern in medical device recalls. One upstream component failure can trigger recalls across several finished products from different companies.

These kits are not consumer products. They are not sold in pharmacies or online to the general public. Typically, they ship directly to hospitals, cardiac catheterization labs, and interventional radiology departments. For example, a patient would never handle the kit or see its packaging. Hospital supply chain staff and clinical teams are the ones who need to check stock against the avid medical recall notice.

The Hazard and Reported Injuries

An angiographic manifold controls fluid flow during imaging procedures. It sits between syringes, contrast dye, saline, and the catheter that enters the patient. Everything passing through that manifold can reach the bloodstream. That is why particulate contamination in the fluid path is treated so seriously.

According to the FDA record, particulates were found within the fluid path of the manifolds. Particulate matter in that location has the potential to enter blood circulation. Once in circulation, particles can travel and become lodged within blood vessels. Blocked vessels can restrict blood flow to tissue downstream. That is the core mechanism of concern described in the agency record.

The FDA classified this recall as Class I. That classification is reserved for situations where use of the product may cause serious injury or death. However, a Class I designation describes potential risk. It does not confirm that harm occurred in any specific patient. The agency record for this avid medical recall does not state whether injuries have been reported. This guide will not speculate either way.

Patients who recently underwent angiography should not assume they were affected. In most cases, hospitals identify and quarantine recalled inventory quickly. If you have questions about a procedure you received, ask the facility directly. They can check whether the recalled lot was in use on your date of service.

Recall number Z-2797-2026
Issuing agency U.S. Food and Drug Administration
Recall date August 12, 2026
Company AVID Medical, Inc.
Product Halyard convenience kits (SAMMC ANGIOGRAPHY, SAMM066-15)
Units affected 5,168
Severity classification Class I

What To Do If You Own This Product

If your facility stocks these kits, stop using them immediately. Pull affected inventory from procedure rooms and storage. Quarantine it in a clearly marked area. Typically, hospitals label recalled stock with a hold tag so no one grabs it by mistake.

Next, identify the product carefully. Check packaging labels for the SAMMC ANGIOGRAPHY designation and code SAMM066-15. Compare your lot numbers against the official notice. For example, a facility may stock similar Halyard kits that are not part of this action. Only the kits containing the recalled Medline Namic manifolds are covered.

The remedy instructions for this avid medical recall should be taken directly from the official FDA notice linked on this page. This guide is not stating the remedy. Follow the instructions in the official notice exactly as written. If anything is unclear, contact AVID Medical, Inc. or your distributor representative before acting.

Patients do not need to take inventory action. However, patients can still be proactive. Ask your provider whether the recalled kits were used in your procedure. Report any unexplained symptoms after an angiography to your physician. You can also report problems to the FDA through the MedWatch program. Keep copies of your procedure records and any correspondence.

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Does a Avid Medical Recall Mean You Can Sue?

A recall is not a lawsuit. That distinction matters. A recall is a corrective safety action taken by a company, sometimes at an agency’s urging. It removes a product from use before harm spreads. It is not a finding of legal fault, and it is not a court proceeding.

As a result, the existence of the avid medical recall does not by itself create a legal claim for anyone. No lawsuit over this specific recall has been verified as of this writing. This guide does not claim one exists. A recall notice is best understood as a safety alert, not a settlement announcement.

Legal claims involving medical devices generally require more than a recall. In most cases, a person must show an actual injury. They must also show a causal link between the device defect and that injury. Medical records, procedure logs, and device tracking data usually carry that burden. Causation is often the hardest element to establish.

If you believe you were harmed during a procedure involving these kits, speak with a licensed attorney in your state. An attorney can review your records and evaluate whether a claim is viable. Depending on the facts, you may be eligible to pursue a claim. However, no outcome is guaranteed, and nothing here promises compensation.

How Recalls Connect to Mass Tort Cases

Recalls and lawsuits are separate, but they often intersect. When litigation does follow a device problem, recall records frequently become evidence. Plaintiffs may point to recall notices to show a company knew about a defect. Defendants may point to the same records to show they acted responsibly and quickly. Courts weigh that context alongside expert testimony and internal documents.

History offers clear examples. The Philips CPAP and BiPAP recall in 2021 involved sound abatement foam that could degrade. Thousands of claims were later consolidated into multidistrict litigation. Similarly, the Takata airbag inflator recalls became one of the largest automotive recalls in U.S. history and generated extensive litigation. In both instances, the recall came first and the legal proceedings followed over years. However, most recalls never produce mass tort litigation at all, and there is no indication that this one will.

Frequently Asked Questions

Which products are covered by this recall?

The recall covers Halyard convenience kits from AVID Medical, Inc. identified as SAMMC ANGIOGRAPHY, code SAMM066-15. These kits contain recalled Medline Namic Angiographic Star Off Handle Manifolds. A total of 5,168 units are affected under recall number Z-2797-2026.

Why is this recall labeled Class I?

Class I is the FDA’s most serious recall category. It is used when there is a reasonable probability that a product may cause serious injury or death. Here, particulates in the manifold fluid path could enter blood circulation and lodge in blood vessels.

Have injuries been reported in connection with this recall?

The FDA record for this recall does not state whether injuries have been reported. This guide will not claim injuries occurred or did not occur. Check the official notice linked on this page for the most current agency information.

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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