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Parker Quality & Compliance

PQC Reg Watch

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Device recall

Convenience Kits containing CONMED AirSeal Access Ports GENERAL DAVINCI DYNJG901004C LAP CHOLE DYNJ88071 ROBOTIC PACK DYNJ50474F

FDA recall source

Recall number
Z-0182-2027
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
LRO
Device type
General Surgery Tray
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
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
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