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

Convenience Kits containing Conmed AirSeal Access Ports Kit recalled

Medline Industries is recalling Convenience Kits containing Conmed AirSeal Access Ports Kit Robotics Urology Prostate, 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 codesDYKMBNDL116G UDI-DI 10198459156991 Lots 24KBD429 24LBE008 24LBH410 25ABF361 25BBI842 25EBM426 25GBG086 25JBF391 25KBA114 25KBN017 25LBQ601

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-0185-2027
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
Device type: Other Medical Devices

Timeline

31 Aug 2026	Recall initiated by company
15 Oct 2026	Classified by FDA	+45 days
21 Oct 2026	Published 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 KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116G

Where it was distributed

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

Nationwide Arizona California Indiana Maryland Missouri New Jersey Ohio Wisconsin

Questions about this recall

Why was it recalled?

Which lots are affected?

DYKMBNDL116G UDI-DI 10198459156991 Lots 24KBD429 24LBE008 24LBH410 25ABF361 25BBI842 25EBM426 25GBG086 25JBF391 25KBA114 25KBN017 25LBQ601

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

This product is part of a recall event; the main page for the event is Convenience Kits containing Conmed AirSeal Access Ports recalled.

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026	CLASS II	Convenience Kits containing Conmed AirSeal Access Ports recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026	CLASS II	Convenience Kits containing Conmed AirSeal Access Ports Chn recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026	CLASS II	Convenience Kits containing Conmed AirSeal Access Ports recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026	CLASS II	Convenience Kits containing Conmed AirSeal Access Ports recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026	CLASS II	Convenience Kits containing Conmed AirSeal Access Ports recalled	Medline Industries	Packaging Defects	Nationwide

More recalls from Medline Industries

All 726

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	Medline surgical convenience kits labeled as: EAR recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Convenience Kits containing Conmed AirSeal Access Ports recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Medline surgical convenience kits labeled as recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Convenience Kits containing Conmed AirSeal Access Ports recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Convenience Kits containing Conmed AirSeal Access Ports recalled	Medline Industries	Packaging Defects	Nationwide

Other Other Medical Devices recalls

All 13,929

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21 Oct 2026Device	CLASS II	Rapicide PA Part A High-Level Disinfectant recalled by Steris	Steris	Other	Nationwide
21 Oct 2026Device	CLASS II	NeuroStar Advanced Therapy System recalled by Neuronetics	Neuronetics	Other	Nationwide
21 Oct 2026Device	CLASS II	TS Misc. Instruments Tray, Triathlon recalled by Howmedica Osteonics	Howmedica Osteonics	Sterility	NJ
21 Oct 2026Device	CLASS II	BD Phoenix Panel Nmic recalled by Becton Dickinson	Becton Dickinson	Device Malfunction	Nationwide
21 Oct 2026Device	CLASS II	BD Phoenix Panel Nmic recalled by Becton Dickinson	Becton Dickinson	Device Malfunction	Nationwide