Recall Summary
| Recall number | Z-3125-2026 |
| Issued by | U.S. Food and Drug Administration |
| Date | 2026-09-23 |
| Company | Medline Industries, LP |
| Units affected | 2,718 |
| 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
Medline Industries recall Z-3125-2026 is a Class I action recorded by the U.S. Food and Drug Administration on September 23, 2026. It covers 2,718 units of two Medline Convenience Kits. The kits contain certain lots of sterile applicators that may carry fungal contamination. Class I is the FDA’s most serious recall category. As a result, healthcare facilities, patients, and caregivers should pay close attention. This guide explains what was recalled, why it matters, and what to do next.
What the Medline Industries Recall Covers
The medline industries recall involves products from Medline Industries, LP. Medline is a large supplier of medical products. The recall centers on convenience kits. A convenience kit bundles several supplies into one package. Clinical staff typically use these kits during a specific procedure. As a result, one kit may hold gauze, drapes, applicators, and other items together.
The FDA record lists two kits by catalog number. The first is DYKM1000B, Catalog Number DYKM1000B. The second is DYKM2187A, Catalog Number DYKM2187A. Together, the two kits account for 2,718 units. However, the concern is not every item in each kit. Instead, it centers on certain lots of sterile applicators packed inside them.
The agency summary we reviewed does not list specific lot codes. It also does not state exact distribution dates or locations. For example, it does not name hospitals, clinics, or states. We will not guess at those details. Instead, check the official FDA notice for complete lot and distribution information. That notice is the most reliable source for identifying affected kits.
Convenience kits like these are typically used in clinical settings rather than at home. They save staff time by grouping supplies for one task. However, patients may still want to know whether a recalled kit was used in their care. In most cases, the facility that treated you can answer that question. Keep this in mind if you had a procedure recently.
The Hazard and Reported Injuries
According to the FDA, the applicators may contain fungal contamination. This contamination may occur under certain environmental conditions. Those conditions can allow the growth of a mold called Aspergillus penicillioides. Sterile applicators are supposed to be free of living organisms. Therefore, any contamination defeats the purpose of a sterile product.
Applicators like these are often used with skin preparation products. Skin prep cleans the skin before a procedure or injection. The goal is to lower the chance of infection. However, the FDA warns that contaminated skin prep can do the opposite. Contamination with Aspergillus penicillioides may lead to serious adverse health consequences. The agency lists systemic infection, sepsis, illness, and death as possible outcomes.
Sepsis is a dangerous body-wide response to infection. It can damage organs and become life-threatening quickly. People with weakened immune systems may face higher risk from fungal exposure. For example, surgical patients or those with open wounds may be more vulnerable. However, individual risk depends on many factors. Your doctor is the right person to assess your situation.
The FDA uses Class I when there is a reasonable probability of serious harm or death. Notably, the agency record does not state whether any injuries have been reported. We cannot say either way. As a result, readers should not assume harm has or has not occurred. The table below summarizes the key facts of this medline industries recall.
| Recall Number | Z-3125-2026 |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Date | September 23, 2026 |
| Company | Medline Industries, LP |
| Products | Medline Convenience Kits DYKM1000B and DYKM2187A |
| Units Affected | 2,718 units |
| Severity | Class I |
What To Do If You Own This Product
Most individuals will not own this product personally. These kits typically go to hospitals, surgery centers, and other care providers. However, any facility that received kits in this medline industries recall should act right away. Stop using any potentially affected kit until you confirm its status. Pause first, then verify. That simple step lowers the chance of exposure.
Start by checking the catalog number on the kit label. Look for DYKM1000B or DYKM2187A. Next, compare the lot information against the official FDA notice. If a kit matches, set it aside in a separate area. Label it clearly so no one uses it by mistake. Do not open the kit or use its applicators.
The remedy for this medline industries recall should come from the official notice. We have not listed a remedy here. Instead, follow the instructions in the official notice linked on this page. You can review it through the
FDA recall enforcement database.
You can also contact Medline Industries, LP directly with questions. In most cases, your distributor or supply manager can help coordinate next steps.
If you are a patient, talk with your healthcare provider. Ask whether a recalled kit was used during your care. Watch for signs of infection, such as fever, chills, or redness near a procedure site. Seek medical care promptly if symptoms appear. Additionally, you can report suspected problems through
FDA MedWatch.
Reports help the agency track product safety.
Does a Medline Industries Recall Mean You Can Sue?
A recall is not a lawsuit. It is a safety action. A recall removes or corrects a product that may pose a risk. The medline industries recall, on its own, does not create a legal claim for anyone. It simply documents a potential hazard. Many people confuse the two, so this distinction matters.
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A legal claim usually requires more than a recall. In most cases, you must show that you suffered an injury. You must also show the product likely caused that injury. For example, a patient would need medical records linking an infection to a recalled applicator. Proving that link can be complex. Typically, it requires expert medical review.
We are not aware of any verified lawsuit tied to this medline industries recall as of September 29, 2026. That could change over time. However, no one can predict whether litigation will follow. We make no promises about outcomes or compensation. Every case depends on its own facts, records, and state law.
If you believe you were harmed, speak with a licensed attorney. Many product liability lawyers offer free consultations. They can review your records and explain your options. Depending on the facts, you may be eligible to pursue a claim. Deadlines called statutes of limitations vary by state. As a result, it helps to ask questions early rather than wait.
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 June 2021. The recall involved sound-abatement foam that could break down. Many lawsuits followed. They were consolidated in federal court in Pennsylvania. Plaintiffs cited the recall as part of their evidence about the defect.
Takata airbags offer another example. Defective inflators could rupture and send metal fragments into vehicle cabins. The resulting recalls became the largest auto safety recall in U.S. history. Injured people and families filed numerous lawsuits. Recall records and company documents played a role in that litigation. In both cases, the recall came first and lawsuits developed later.
Still, most recalls never lead to mass tort litigation. Typically, litigation grows only when many people report similar injuries. Those injuries must also be linked to the same product. As a result, a medline industries recall today does not signal future lawsuits. It documents a safety risk, and staying informed is the best next step.
Frequently Asked Questions
What products are part of the medline industries recall?
The recall covers Medline Convenience Kits with catalog numbers DYKM1000B and DYKM2187A. It affects 2,718 units in total. The concern involves certain lots of sterile applicators inside the kits.
Why did the FDA classify this as a Class I recall?
Class I is the FDA’s most serious recall category. The applicators may contain Aspergillus penicillioides contamination. The agency warns this may lead to systemic infection, sepsis, illness, and death.
Can I file a lawsuit because of the medline industries recall?
A recall alone is not a lawsuit or a legal claim. You would typically need an injury and evidence that the product caused it. A licensed attorney can review your situation and explain whether you may be eligible.
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 September 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.