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Convenience Kits containing CONMED AirSeal Access Ports recallZ-0181-2027 · Medline Industries, LP · initiated Aug 31, 2026

Open, Classified All recalls posted in October 2026

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medline Industries, LP or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Process change control

What the company is doing

The firm began notifying customers on August 31, 2026. Customers were provided with CONMED's original recall notification, which instructs users to have a replacement AirSeal disposable be available prior to the procedure in order to minimize potential delays. Users should ensure tubing is properly connected between the tube set and access ports prior to initiating insufflation. If the connection cannot be securely tightened and the "overpressure" alert cannot be resolved, users should replace the affected device. Users were also provided with instructions on how to connect the AirSeal tubeset and access ports, which include new figures as an update to the prior Instructions for Use. The corrected Instructions for Use are available electronically at eifu.conmed.com/eifu.

Recall details

Recall number
Z-0181-2027
Recall class
Not yet classified by the FDA
Status
Open, Classified
Initiated by the company
Aug 31, 2026
Posted by the FDA
Oct 15, 2026
Recalling firm
Medline Industries, LP
Quantity
3,551 kits
Product code
LRO
Distribution
US Nationwide distribution in the states of AZ, CA, IN, MD, MO, NJ, OH, and WI.

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

4 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 99888).

Sources and updates

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