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 Hernandez Davinci Acc Bundle M, 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 codesDYNJ911258 UDI-DI 10198459306723 Lots 25DMC798 25EMD961 25FMB704 25FMB704Z 25JMG936 25JMI469 DYKMBNDL116I UDI-DI 10198459644764 Lots 26ABL226 26BBD710 26EBC888 26EBH673 DYNJ910997 UDI-DI 10198459241987 Lots 25DMB772 25GMA914 25GMB737 25GMC286 25GMJ509 25IMB332 25IME774 25KMB190 25KMF850 25LMB486 DYNJ910997A UDI-DI 10198459582103 Lots 25LLA437 26BLA786 26CLB107 26DLA500 26DLB085 26FLA287 26GLA058 26GLA968 26GLB068 DYNJ63392D UDI-DI 10198459164507 Lots 25ALA298 25BLA967 DYNJ908720B UDI-DI 10198459642517 Lots 26EBE658 DYNJ85189 UDI-DI 10195327473754 Lots 24AMA883
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-0181-2027
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 HERNANDEZ DAVINCI ACC BUNDLE M DYNJ911258 KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116I ROBOTIC CHEST DYNJ910997 DYNJ910997A RR-DAVINCI PROSTATE ACCESSORY DYNJ63392D UROLOGY LAPAROSCOPIC - 51638 DYNJ908720B UROLOGY ROBOT ADD ON PACK DYNJ85189

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?

DYNJ911258 UDI-DI 10198459306723 Lots 25DMC798 25EMD961 25FMB704 25FMB704Z 25JMG936 25JMI469 DYKMBNDL116I UDI-DI 10198459644764 Lots 26ABL226 26BBD710 26EBC888 26EBH673 DYNJ910997 UDI-DI 10198459241987 Lots 25DMB772 25GMA914 25GMB737 25GMC286 25GMJ509 25IMB332 25IME774 25KMB190 25KMF850 25LMB486 DYNJ910997A UDI-DI 10198459582103 Lots 25LLA437 26BLA786 26CLB107 26DLA500 26DLB085 26FLA287 26GLA058 26GLA968 26GLB068 DYNJ63392D UDI-DI 10198459164507 Lots 25ALA298 25BLA967 DYNJ908720B UDI-DI 10198459642517 Lots 26EBE658 DYNJ85189 UDI-DI 10195327473754 Lots 24AMA883

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.

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