Recall Summary
| Recall number | Z-3154-2026 |
| Issued by | U.S. Food and Drug Administration |
| Date | 2026-09-23 |
| Company | AVID Medical, Inc. |
| Units affected | 340 |
| 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
avid medical recall Z-3154-2026 involves a medical procedure kit used during image-guided biopsies. The U.S. Food and Drug Administration posted the recall on September 23, 2026. The company is AVID Medical, Inc. The recalled product is the Haylard UNIV IMAGING BIOPSY TRUCUSTOM kit, model number VARV042-03. The problem is the sodium chloride ampules packed inside the kit. Spectra Medical has recalled those ampules separately. As a result, the kits may have product quality and sterility issues. This guide explains what that means for you.
What the Avid Medical Recall Covers
This avid medical recall covers one specific custom procedure kit. The FDA record lists it as the Haylard UNIV IMAGING BIOPSY TRUCUSTOM. The kit model or item number is VARV042-03. The FDA lists the scope as 340 units. The record does not list any other kit models.
Custom procedure kits bundle many single-use items into one sterile package. For example, a biopsy kit may hold drapes, needles, syringes, gauze, and saline. Hospitals order these kits so staff can set up procedures faster. However, when one part of a kit is recalled, the whole kit may be affected. That is what happened here.
The issue traces back to sodium chloride ampules made or supplied by Spectra Medical. Spectra Medical recalled those ampules. AVID Medical then recalled its kits that contain them. In most cases, this kind of “downstream” recall follows a component recall. The kit maker had no separate defect of its own listed in the record.
Typically, patients do not buy biopsy kits themselves. Hospitals, clinics, and imaging centers buy them through medical suppliers. As a result, most readers will never see the kit packaging. Still, patients may want to know whether a recalled kit was used during their procedure. The official FDA notice is the best source for any distribution details.
The Hazard and Reported Injuries
The FDA describes the hazard as a “potential for product quality and sterility issues.” The concern centers on the sodium chloride ampules inside the kit. Saline is often used to flush, rinse, or moisten during a procedure. A biopsy also breaks the skin and reaches internal tissue. As a result, sterility is very important.
When a sterile product may not be sterile, infection is the main general concern. For example, contaminated fluid used near an open site could introduce germs. However, the FDA record does not describe a specific failure or contamination finding. It describes a potential problem. Readers should not assume harm occurred in any particular case.
The FDA rated this avid medical recall as Class I. That is the agency’s most serious category. The FDA uses Class I when there is a reasonable probability that a product could cause serious health problems or death. However, the classification describes risk. It does not confirm that anyone was hurt.
The agency record does not state whether any injuries have been reported. We cannot say either way. If you had a biopsy and later developed symptoms, talk to your doctor. Signs of infection can include fever, redness, swelling, or drainage at the site. Your doctor can judge your own situation.
| Detail | Information |
|---|---|
| Recall number | Z-3154-2026 |
| Agency | U.S. Food and Drug Administration |
| Date | September 23, 2026 |
| Company | AVID Medical, Inc. |
| Product | Haylard UNIV IMAGING BIOPSY TRUCUSTOM (Kit VARV042-03) |
| Units affected | 340 units |
| Severity | Class I |
What To Do If You Own This Product
Most owners of this kit will be healthcare facilities, not individuals. If your facility stocks medical kits, check your inventory right away. Look for the product name Haylard UNIV IMAGING BIOPSY TRUCUSTOM. Then confirm the kit number VARV042-03 on the label. Stop using any matching kits until you review the official notice.
The remedy for this avid medical recall should come from the official notice. Do not rely on secondhand summaries. Follow the instructions in the FDA notice here: FDA device recall database. Search for recall number Z-3154-2026. The notice and any company letter will explain the next steps.
Patients have a different role. You likely did not handle the kit yourself. However, you can ask your provider whether a recalled kit was used during your biopsy. Typically, facilities keep records of supplies used in procedures. Ask for your procedure records if you have concerns. Keep copies of anything you receive.
You can also report problems to the FDA. The agency runs MedWatch, its safety reporting program. Patients, doctors, and facilities can all file reports there. In addition, you can contact AVID Medical, Inc. directly with product questions. Write down the date, the person you spoke with, and what they said.
Does an Avid Medical Recall Mean You Can Sue?
A recall is not a lawsuit. It is a safety action. A company removes or corrects a product, often with FDA oversight. The avid medical recall is a step to reduce risk. It is not a legal finding that anyone was harmed. It is also not a court ruling against the company.
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A recall alone does not create a legal claim. In most cases, a product liability claim needs more. You would typically need to show an actual injury. You would also need to show the product caused that injury. For example, a person would need evidence linking an infection to a recalled kit. That can be hard to prove.
We have not verified any lawsuit tied to this avid medical recall. That could change over time. However, no one should assume a case exists. If you believe you were harmed, speak with a licensed attorney in your state. Many offer free consultations. A lawyer can review your records and explain your options.
No one can promise an outcome. Depending on the facts, you may be eligible to pursue a claim. You may also find you have no claim at all. Time limits, called statutes of limitations, apply to injury cases. As a result, it is wise to ask questions early if you have concerns.
How Recalls Connect to Mass Tort Cases
Recalls sometimes become evidence in later litigation. For example, Philips recalled millions of CPAP and ventilator devices in 2021. The concern was sound-reducing foam that could break down. Many users later filed lawsuits. Those cases were grouped into federal multidistrict litigation in Pennsylvania. The recall notice became an important document in those cases.
Takata airbags offer another example. Defective inflators could rupture and send metal fragments into vehicles. That led to one of the largest auto recalls in U.S. history. Injury lawsuits followed and were consolidated in federal court in Florida. However, not every recall leads to a mass tort. Most recalls never reach court. Whether litigation follows depends on injuries, evidence, and many other factors.
The avid medical recall is still recent. At this point, the record shows a potential sterility risk, not confirmed injuries. In most cases, lawyers watch for patterns of harm before cases form. Readers should follow official FDA updates rather than rumors. Accurate information is the best protection.
Frequently Asked Questions
What product is included in the avid medical recall?
The recall covers the Haylard UNIV IMAGING BIOPSY TRUCUSTOM kit, model VARV042-03. The FDA lists 340 units. The concern is sodium chloride ampules inside the kit that Spectra Medical recalled.
Have any injuries been reported?
The FDA record does not state whether injuries have been reported. We cannot confirm either way. If you have health concerns after a biopsy, contact your doctor.
Does this avid medical recall mean I have a lawsuit?
No. A recall is a safety action, not a lawsuit. If you believe a recalled kit harmed you, a licensed attorney can review whether you may be eligible to file 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 October 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.