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Parker Quality & Compliance

PQC Reg Watch

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Device recall

Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911135 LAP CHOLE DYNJ911660 LAP NISSEN DYNJ911560 UROLOGY LAPAROSCOPIC - 51638 DYNJ908720A

FDA recall source

Recall number
Z-0180-2027
Event id
99888
Status
Ongoing
FDA classification
Class II
Recalling firm
Medline Industries, LP
Report date
Oct 21, 2026
Posted
Oct 15, 2026
Initiated
Aug 31, 2026
Center classification date
Oct 15, 2026
Product code
FDE
Device type
Laparoscopy Kit
Reason
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.
Root cause
Process change control
Quantity
3,551 kits
Code info
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
Distribution
US Nationwide distribution in the states of AZ, CA, IN, MD, MO, NJ, OH, and WI.
Voluntary or mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States