Medline Convenience Kit Recall Z-0183-2027 Recall

Medline Industries, LP recalled 3,551 convenience kits that contain CONMED AirSeal Access Ports. The Food and Drug Administration assigned the action recall number Z-0183-2027 and classified it Class II on October 15, 2026. The stated reason is that the ports were recalled by their manufacturer over possible erroneous overpressure alerts and system venting during use, which may delay or end procedures. Medline initiated the recall on August 31, 2026.

At a glance

• The recalling firm is Medline Industries, LP of Northfield, Illinois, and the recall number is Z-0183-2027.
• The FDA classified the action as Class II on October 15, 2026, and published it in its enforcement report on October 21, 2026.
• The record lists 3,551 kits and distribution to eight states: AZ, CA, IN, MD, MO, NJ, OH, and WI.
• The recall was firm initiated and voluntary, and the initial notification to customers was by letter.
• The listed reason is that the kits contain CONMED AirSeal Access Ports that the port manufacturer recalled over possibly erroneous overpressure alerts and system venting during use.

What triggered the Medline convenience kit recall

The FDA enforcement record states the reason plainly. The affected kits contain CONMED AirSeal Access Ports, and those ports were recalled by their manufacturer. The manufacturer’s stated concern was the potential for erroneous overpressure alerts and system venting during use. According to the record, either event may result in delays to a procedure or in a procedure being ended.

The recall covers a broad set of kit configurations. The product description names kits including CHN GYN ONCOLOGY, DAVINCI PROSTATECTOMY, GENERAL DAVINCI, HERNANDEZ DAVINCI ACC BUNDLE M, KIT ROBOTICS UROLOGY PROSTATE, ROBOTIC GYN, ROBOTIC PACK, and RR-DAVINCI PROSTATE ACCESSORY kits. Each configuration is tied to specific catalog numbers, UDI-DI codes, and lot numbers. The record identifies 18 catalog numbers, including DYNJ906731K, DYNJ906731L, DYNJ906731N, DYNJG901002A through DYNJG901002D, and DYNJG901004B and DYNJG901004D. The listed lots carry date-coded prefixes, which is the conventional format for device lot identification, though the record does not decode them.

Distribution was not national in scope. The FDA record lists US distribution in eight states only.

What is established vs. what is alleged

Established facts come from the FDA enforcement record itself. The record establishes that Medline Industries, LP initiated a voluntary recall on August 31, 2026, that the FDA classified it Class II on October 15, 2026, and that the report date was October 21, 2026. It establishes the product quantity, the catalog and lot identifiers, the distribution states, the notification method, and the recall status of Ongoing. The reason for the recall, as recorded, is that the kits contain CONMED AirSeal Access Ports that the port manufacturer recalled over potential erroneous overpressure alerts and system venting.

Not established by these documents is any injury, any patient harm, or any adverse event tied to the affected kits. The record describes a potential effect on procedures, not a reported outcome. Nothing in the source documents states that a procedure was in fact delayed or ended for any patient, and nothing identifies a patient or a facility. The documents also do not identify the CONMED recall number, the FDA classification of the underlying port recall, or the date the port manufacturer initiated its own action. All of that lies outside the supplied record.

Any characterization of the recall as negligent, unlawful, or the basis of a legal claim would be an allegation, not a finding. No court has decided anything about this recall in the supplied documents.

Where the claims stand procedurally

The relevant procedure here is regulatory, not judicial. The recall is recorded in the FDA’s medical device recall database, which the agency describes as containing device recalls classified since November 2002. Under that database’s own explanation, recall classification may occur after a firm communicates with its customers, and the posting date reflects the date the FDA classified the recall rather than the date the recall began. That is why Z-0183-2027 shows an August 31, 2026 initiation date and an October 15, 2026 classification date.

The status field reads Ongoing. The database notes that status is updated when the FDA identifies a violation and classifies an action as a recall and again when the recall is terminated. A status of Ongoing therefore indicates the action had not been recorded as terminated as of the data’s last update.

No federal consolidation exists for this recall in the supplied documents. There is no MDL (multidistrict litigation, a procedure that consolidates related federal lawsuits before one judge) number, no court, no docket, no bellwether trial (a test trial used to gauge how similar cases may resolve), and no filed complaint identified anywhere in the record. Readers comparing this with device litigation that does have a procedural home can review the Bard implanted port catheter litigation overview or the Bair Hugger litigation overview for how consolidated matters are structured. Those matters are separate from this recall.

Key dates

• August 31, 2026: Medline Industries, LP initiated the voluntary recall of the affected convenience kits.
• October 15, 2026: the FDA classified the action as Class II.
• October 21, 2026: the FDA published the recall in its enforcement report, and openFDA’s data carried that last-updated date.
• October 21, 2026: the record lists the recall status as Ongoing.

What this does not establish

The record does not establish that any patient was harmed. It describes a potential for erroneous overpressure alerts and system venting, and a potential for procedural delay or termination, not a confirmed clinical event.

The record does not establish liability, fault, or a violation of law by Medline Industries, LP or by the port manufacturer. An FDA recall classification is an administrative designation, not a judicial finding. A Class II designation means the FDA’s stated view is that use of or exposure to the product may cause temporary or medically reversible adverse health consequences or that the probability of serious adverse health consequences is remote, but the supplied documents do not restate that definition, so it is not asserted here.

The record does not establish a settlement, a verdict, a court order, or a pending lawsuit of any kind. It does not establish that any kit outside the listed catalog numbers and lots was affected, and it does not establish that every kit in distribution reached a patient. It also does not establish the terms of the customer letter, the return or replacement process, or whether any regulatory follow-up occurred after October 21, 2026.

Frequently asked questions

What is FDA recall Z-0183-2027?

FDA recall Z-0183-2027 is a Class II recall by Medline Industries, LP covering 3,551 convenience kits that contain CONMED AirSeal Access Ports. The FDA classified the action on October 15, 2026, and published it on October 21, 2026. The record lists the recall status as Ongoing.

Why were the kits recalled?

The FDA enforcement record states that the kits contain CONMED AirSeal Access Ports that the port manufacturer recalled. The manufacturer’s stated concern was potential erroneous overpressure alerts and system venting during use. The record says those events may result in delays or in ending procedures.

What does Class II mean for this Medline Industries, LP recall?

Class II is one of three FDA recall classifications, assigned in the agency’s database of device recalls classified since November 2002. The supplied documents do not restate the agency’s definition of Class II, so this article does not characterize the health risk beyond what the record says. The classification date for Z-0183-2027 was October 15, 2026.

Is there a lawsuit or MDL about these convenience kits?

The supplied documents identify no lawsuit, no MDL number, and no court connected to the Medline convenience kit recall. The only recorded action is the FDA-regulated recall itself. Any claim of litigation would require a court record that these sources do not contain.

Which products and states are covered?

The record lists 18 catalog numbers with corresponding UDI-DI codes and lot numbers, spanning kit types such as CHN GYN ONCOLOGY, DAVINCI PROSTATECTOMY, ROBOTIC GYN, and ROBOTIC PACK. Distribution is listed for AZ, CA, IN, MD, MO, NJ, OH, and WI. The total product quantity is 3,551 kits.

Sources

1. U.S. Food and Drug Administration (openFDA): “Device Enforcement Report, recall number Z-0183-2027” (link, accessed 2026-10-30)
2. U.S. Food and Drug Administration: “510(k) Premarket Notification Database” (link, accessed 2026-10-30)
3. U.S. Food and Drug Administration: “Medical Device Recalls Database” (link, accessed 2026-10-30)
4. U.S. Food and Drug Administration (openFDA): “Device Enforcement Report, general query” (link, accessed 2026-10-30)
5. U.S. Food and Drug Administration (openFDA): “510(k) Premarket Notification, general query” (link, accessed 2026-10-30)
6. U.S. Food and Drug Administration: “Medical Devices” (link, accessed 2026-10-30)
7. U.S. Food and Drug Administration: “Device Advice: Comprehensive Regulatory Assistance” (link, accessed 2026-10-30)