CLASS II ONGOING Device recall · Reported 21 Oct 2026 · FDA Enforcement Report

Convenience Kits containing Conmed AirSeal Access Ports recalled

Medline Industries is recalling Convenience Kits containing Conmed AirSeal Access Ports Advance Laparoscopic DYNJ911135A, distributed nationwide in the US. The recall was initiated on 31 Aug 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesDYNJ911135A UDI-DI 10198459655623 Lot 26EDA606 DYNJ906731M UDI-DI 10198459567117 Lots 25KDA658 25KDB571 25LDB411 26CDA536
Quantity recalled3,551 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-0184-2027
FDA event ID
99888
Recalling firm
Medline Industries, Northfield, IL
Classification
Class II
Status
Ongoing
Recall initiated
31 Aug 2026
FDA classified
15 Oct 2026
Reported
21 Oct 2026
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Packaging Defects

Timeline

31 Aug 2026Recall initiated by company
15 Oct 2026Classified by FDA+45 days
21 Oct 2026Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911135A CHN GYN ONCOLOGY DYNJ906731M

Where it was distributed

US Nationwide distribution in the states of AZ, CA, IN, MD, MO, NJ, OH, and WI.

Nationwide ArizonaCaliforniaIndianaMarylandMissouriNew JerseyOhioWisconsin

Questions about this recall

Why was it recalled?

Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.

Which lots are affected?

DYNJ911135A UDI-DI 10198459655623 Lot 26EDA606 DYNJ906731M UDI-DI 10198459567117 Lots 25KDA658 25KDB571 25LDB411 26CDA536

Where was it sold?

US Nationwide distribution in the states of AZ, CA, IN, MD, MO, NJ, OH, and WI.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 27 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

5 other products · FDA event 99888

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