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Convenience Kits containing CONMED AirSeal Access Ports recallZ-0180-2027 · 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-0180-2027
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
FDE
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 ADVANCE LAPAROSCOPIC DYNJ911135 LAP CHOLE DYNJ911660 LAP NISSEN DYNJ911560 UROLOGY LAPAROSCOPIC - 51638 DYNJ908720A

Code information (models, lots, serial numbers)

DYNJ911135 UDI-DI 10198459264382 Lots 25EDA279 25FDB612 25LDB658 DYNJ911660 UDI-DI 10198459487071 Lots 25IMF444 25JMA458 26BMG519 26DMA914 26EMA779 26FME775 26GMA849 26GMF826 26GMM101 26GMM127 DYNJ911560 UDI-DI 10198459400261 Lots 25HMG749 25JMC886 25KMA383 25KMA392 DYNJ908720A UDI-DI 10195327423155 Lots 24DBN292 24GBJ114 24IBK504 24JBC471 25KBP733 26ABG732

Devices named in this recall

3 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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