Z-0182-2027Class II

Convenience Kits containing CONMED AirSeal Access Ports GENERAL DAVINCI DYNJG901004C LAP CHOLE DYNJ88071...

Name: Z-0182-2027 Convenience Kits containing CONMED AirSeal Access Ports GENERAL DAVINCI DYNJG901004C LAP CHOLE DYNJ88071...
Creator: Medline Industries, LP
Published: 2026-08-31
License: https://open.fda.gov/license/

Medline Industries, LP / initiated 2026-08-31 / Open, Classified

FDA source

Recall record

Recall number: Z-0182-2027
Classification: Class II
Status: Open, Classified
Initiated: 2026-08-31
Posted: 2026-10-15
Recalling firm: Medline Industries, LP
Product: Convenience Kits containing CONMED AirSeal Access Ports GENERAL DAVINCI DYNJG901004C LAP CHOLE DYNJ88071 ROBOTIC PACK DYNJ50474F
Product code: LRO General Surgery Tray
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.
FDA root cause: Process change control
Action: 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.
Quantity in commerce: 3,551 kits
Distribution: US Nationwide distribution in the states of AZ, CA, IN, MD, MO, NJ, OH, and WI.
Product codes and lots: DYNJG901004C UDI-DI 10198459535772 Lots 25LLA307 26BLA900 DYNJ88071 UDI-DI 10198459098512 Lots 24KMD416 24LMG268 25AMH987 25BMA076 25GMK411 DYNJ50474F UDI-DI 10195327559007 Lots 24DDA107 24DDA469 24EDA512 24GDB884 24IDA882

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0182-2027
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0180-2027	Class II	Ongoing	Voluntary: Firm initiated	2026-10-21	2026-10-15
Z-0181-2027	Class II	Ongoing	Voluntary: Firm initiated	2026-10-21	2026-10-15
Z-0182-2027	Class II	Ongoing	Voluntary: Firm initiated	2026-10-21	2026-10-15
Z-0183-2027	Class II	Ongoing	Voluntary: Firm initiated	2026-10-21	2026-10-15
Z-0184-2027	Class II	Ongoing	Voluntary: Firm initiated	2026-10-21	2026-10-15
Z-0185-2027	Class II	Ongoing	Voluntary: Firm initiated	2026-10-21	2026-10-15

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-28, the FDA export date for this dataset. Page last changed 2026-10-21. View this recall on fda.gov (opens on fda.gov)