Medline Surgical Kit Recall Z-0177-2027: FDA Class II

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Medline Industries, LP recalled 1,900 surgical convenience kits because the kits contained cannula components that do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use. The US Food and Drug Administration assigned the action recall number Z-0177-2027 and classified it Class II. The FDA record lists the recall as ongoing. The affected products are the NEURO-SPINE BASIN PACK (SKU DYNJ80055A) and the AV SHUNT PACK-LF (SKU DYNJ24528M).

At a glance

Recalling firm: Medline Industries, LP of 3 Lakes Dr, Northfield, Illinois.
FDA recall number Z-0177-2027, classified Class II with a center classification date of October 15, 2026.
Medline initiated the action on September 2, 2026, and the FDA published it in its enforcement report on October 21, 2026.
Quantity: 1,900 kits, distributed nationwide in the United States.
FDA lists the action as “Voluntary: Firm initiated” and the status as ongoing.

What was recalled and why

The FDA enforcement record describes the products as Medline surgical convenience kits labeled as the NEURO-SPINE BASIN PACK, Medline product number and SKU DYNJ80055A, and the AV SHUNT PACK-LF, Medline product number and SKU DYNJ24528M.

The stated reason for the recall is that medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use. ISO 80369-7 is a dimensional standard for small-bore connectors used in medical devices. The FDA record does not say which lots shipped to which customers or where any particular kit was used.

Each product number carries two device identifiers, one for the individual unit and one for the case: 10198459093425 (each) and 40198459093426 (case) for DYNJ80055A, and 10193489678222 (each) and 40193489678223 (case) for DYNJ24528M. The record also lists individual lot numbers for each SKU, running from 2020 into 2026 depending on the product.

The firm’s initial notification used two or more of the following: email, fax, letter, press release, telephone, visit. The FDA record does not identify which combination Medline used.

What a Class II classification means

The FDA sorts device recalls into three classes by the risk the agency associates with the problem. The agency’s own database describes its recall records as classified actions. In this entry, the FDA assigned Class II to Z-0177-2027. The record supplied here does not include the FDA’s definitional language for that class, so the specific risk wording for this recall should be read on the FDA record rather than inferred.

Classification is an agency action, not a finding that anyone was injured. The enforcement record for Z-0177-2027 contains no injury reports, no patient counts and no adverse event data.

What is established vs. what is alleged

Established by the FDA record:

Medline Industries, LP initiated a recall of 1,900 kits on September 2, 2026.
The FDA classified the action as Class II on October 15, 2026 and reported it on October 21, 2026.
The two affected SKUs are DYNJ80055A and DYNJ24528M, and both are described as surgical convenience kits.
Distribution was nationwide within the United States.
The stated reason concerns cannula components not conforming to ISO 80369-7 dimensional requirements.

Not established by the record:

That any patient was harmed, or that any kit leaked or broke in use.
That the nonconforming components were manufactured by Medline rather than supplied to it; the record names only the kits and their components.
That a recall of this size or class reflects a legal finding of defect.

A recall record is a regulatory action described by the firm and published by the agency. It is not a court ruling, and no court has made any finding about these kits in the documents reviewed here.

Where the claims stand procedurally

There is no federal consolidation of claims about these Medline surgical convenience kits. The Judicial Panel on Multidistrict Litigation (JPML), the body that can combine similar federal lawsuits before one judge as a multidistrict litigation (MDL), has not been reported to have created one for Z-0177-2027, and no MDL number appears in the source documents.

The action is a regulatory recall, not litigation. No complaint, docket number, trial date or verdict involving these two SKUs appears in the sources reviewed. Readers comparing this with consolidated device matters can review how MDL structures work in other device contexts, such as the Bard implanted port catheter litigation overview and the Bair Hugger litigation overview, but those matters involve different products and different records.

The site also covers a separate Medline action concerning different convenience kits, the Medline Industries convenience kits containing ConMed AirSeal components. The two recalls involve different products and different reasons for recall.

Key dates

September 2, 2026: Medline Industries, LP initiated the recall of the two kit SKUs.
October 15, 2026: The FDA center classification date for Z-0177-2027, recorded as Class II.
October 21, 2026: The FDA enforcement report date and the last update to the openFDA device enforcement dataset used here.
October 26, 2026: The FDA’s 510(k) premarket notification database page shows that update date; that database is not specific to this recall.
October 30, 2026: The FDA’s medical device recalls database page shows that update date; that database is not specific to this recall.

What this does not establish

The record does not show that any recalled kit was used on a patient, that any device failure occurred, or that anyone was injured. It does not identify a manufacturer of the cannula components separate from Medline. It does not state whether any product was returned or destroyed, and it does not give a termination date for the recall, which the FDA lists as ongoing.

The record also does not show that the FDA inspected Medline’s facility in connection with this action, or that the firm changed any manufacturing process. Nothing in the documents reviewed states a dollar amount, a settlement, or a claim by any purchaser or patient.

Frequently asked questions

Which Medline products are covered by recall Z-0177-2027?

The FDA record for recall number Z-0177-2027 names two Medline surgical convenience kits: the NEURO-SPINE BASIN PACK, SKU DYNJ80055A, and the AV SHUNT PACK-LF, SKU DYNJ24528M. The action covers 1,900 kits distributed nationwide in the United States. The record also lists individual lot numbers for each SKU.

Why did Medline recall these surgical convenience kits?

The FDA enforcement record states that the kits contained cannula components that do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use. ISO 80369-7 is a dimensional standard for small-bore medical connectors. The record does not report any injury or confirmed device failure.

What does FDA Class II mean for this recall?

The FDA assigned Class II to recall number Z-0177-2027 on its center classification date of October 15, 2026. Classification is an FDA action based on the risk the agency associates with the problem, and the record supplied here does not reproduce the FDA’s class definitions. A classification is not a court finding and does not by itself establish that anyone was harmed.

Is there an MDL or class action for the Medline kit recall?

No federal multidistrict litigation is reported for recall Z-0177-2027 in the source documents reviewed, and no MDL number appears. The action is a firm-initiated recall published by the FDA, not a lawsuit. Any future litigation would be a separate development and would not change the recall record itself.

Who was notified about the recall?

The FDA record states that Medline Industries, LP used two or more of the following notification methods: email, fax, letter, press release, telephone, visit. The record does not specify which combination was used or the dates of individual notices. It also lists the recall status as ongoing as of the October 21, 2026 report date.

Sources

U.S. Food and Drug Administration (openFDA): “Device Enforcement Report, recall number Z-0177-2027” (link, accessed 2026-10-21)
U.S. Food and Drug Administration: “510(k) Premarket Notification Database” (link, accessed 2026-10-26)
U.S. Food and Drug Administration: “Medical Device Recalls Database” (link, accessed 2026-10-30)
U.S. Food and Drug Administration (openFDA): “Device Enforcement Report, general query” (link, accessed 2026-10-21)
U.S. Food and Drug Administration (openFDA): “510(k) Premarket Notification data, general query” (link, accessed 2026-10-19)
U.S. Food and Drug Administration: “Medical Devices” (link, accessed 2026-10-30)
U.S. Food and Drug Administration: “Device Advice: Comprehensive Regulatory Assistance” (link, accessed 2026-10-30)

CollectiveClaim.us publishes general legal information. This article is not legal advice and does not create an attorney–client relationship. Court records and agency actions change; verify current status with the court or agency before relying on it.

medical device litigation, Medline Industries, FDA Class II recall, surgical convenience kits, ISO 80369-7