Convenience Kits containing CONMED AirSeal Access Ports recallZ-0185-2027 · Medline Industries, LP · initiated Aug 31, 2026
Open, Classified All recalls posted in October 2026
Is my device affected?
- 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.
- 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.
- 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-0185-2027
- 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
- OKV
- 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 KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116G
Code information (models, lots, serial numbers)
DYKMBNDL116G UDI-DI 10198459156991 Lots 24KBD429 24LBE008 24LBH410 25ABF361 25BBI842 25EBM426 25GBG086 25JBF391 25KBA114 25KBN017 25LBQ601
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Medline Industries, Inc. DYKMBNDL116GMedline Industries, Inc. · Obstetrical kit5 recalls0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 99888).
- Z-0180-2027 · Open, ClassifiedConvenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911135 LAP CHOLE DYNJ911660 LAP NISSEN DYNJ911560 UROLOGY LAPAROSCOPIC - 51638 DYNJ90…
- Z-0181-2027 · Open, ClassifiedConvenience Kits containing CONMED AirSeal Access Ports HERNANDEZ DAVINCI ACC BUNDLE M DYNJ911258 KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116I ROBOTIC CHEST DYNJ910997 DYNJ…
- Z-0182-2027 · Open, ClassifiedConvenience Kits containing CONMED AirSeal Access Ports GENERAL DAVINCI DYNJG901004C LAP CHOLE DYNJ88071 ROBOTIC PACK DYNJ50474F
- Z-0183-2027 · Open, ClassifiedConvenience Kits containing CONMED AirSeal Access Ports CHN GYN ONCOLOGY DYNJ906731K DYNJ906731L DYNJ906731N DAVINCI PROSTATECTOMY DYNJG901002A DYNJG901002B …
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 21, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 21, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 21, 2026. Text above is shown as published by the FDA.
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